Superbium

K153229 · Bios S.R.L. · GEX · Apr 12, 2016 · General, Plastic Surgery

Device Facts

Record IDK153229
Device NameSuperbium
ApplicantBios S.R.L.
Product CodeGEX · General, Plastic Surgery
Decision DateApr 12, 2016
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for: -treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins; -treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; -tattoos (significant reduction in the intensity of black and/or blue-black tattoos); verrucae, skin tags, seborrheic keratosis; - reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; - coagulation and hemostasis of soft tissue; -the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for: Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of: - Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas -Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis -Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques - Pigmented benign lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles; Perioral wrinkles; -Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. -Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of: -Incision, excision, ablation, vaporization of soft tissue. - Tattoo removal: Light blue; Yellow; Red; Green - Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi -Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi -Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques The 2940 nm Er:YAG Laser Module handpiece is indicated for: Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles The 2940 nm Er: Yag Fractional tips are indicated for: Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. IPL 400-1200 run handpiece is indicated for: - The treatment of moderate inflammatory acne vulgaris. - The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). - The treatment of benign cutaneous lesions including warts, scars and striae. - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. -Use on all skin types (Fitzpatrick I-VI). IPL500-1200 nm handpiece is indicated for: - The treatment of moderate inflammatory acne (acne vulgaris). - The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. - The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. -Use on Fitzpatrick skin types I-V. IPL 550-1200 nm handpiece is indicated for: - The treatment of moderate inflammatory acne Vulgans. - The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). - The treatment of face and body vascular and pigmented lesions. - The treatment of cutaneous lesions, including scars and striae. - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Use on all skin types (Fitzpatrick I-VI). IPL 580-1200 run handpiece is indicated for: - The treatment of moderate inflammatory acne vulgaris. - The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). - The treatment of face and body vascular and pigmented lesions. - The treatment of cutaneous lesions, including scars and striae. - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Use on all skin types (Fitzpatrick I-VI). IPL 620-1200 nm handpiece is indicated for: - The treatment of tattoos. - The treatment of moderate inflammatory acne vulgaris. - The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait. - The treatment of cutaneous lesions including warts, scars and striae. - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. - The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Use on all skin types (Fitzpatrick I-VI), including tanned skin. IPL 755-1200 nm handpiece is indicated for: - The treatment of tattoos. - The treatment of moderate inflammatory acne vulgaris. - The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). - The treatment of cutaneous lesions including warts, scars and striae. - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. - The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis. - The treatment of pseudofolliculitis barbae (PFB). - The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. -Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Device Story

Superbium is a modular, portable multi-laser and pulsed light system for dermatologic and general surgery. Platform contains electronics and cooling; supports interchangeable handpieces (Nd:YAG Long/Short Pulse, Q-Switched 1064/532nm, Er:YAG 2940nm, Er:Glass 1540nm, IPL 400-1200nm). Inputs: electrical power; operator-selected parameters via touchscreen. Operation: flash lamp-excited laser or xenon lamp (IPL) sources; cooling circuit for thermal management. Outputs: laser/IPL energy delivered to skin. Used in clinics by physicians; operator guided by pointing laser (for laser handpieces). Output affects tissue via coagulation, vaporization, ablation, or selective photothermolysis; benefits include lesion clearance, hair reduction, and skin resurfacing.

Clinical Evidence

Bench testing only. No clinical or animal studies were required to demonstrate substantial equivalence. Performance data includes electrical safety (EN 60601-1), EMC (EN 60601-1-2), software verification/validation, and usability testing (EN 60601-1-6).

Technological Characteristics

Modular platform with interchangeable handpieces. Energy sources: Nd:YAG (1064/532nm), Er:YAG (2940nm), Er:Glass (1540nm), Xenon lamp (IPL 400-1200nm). Features: touch screen control, integrated cooling system, class IV laser classification. Electrical: 110V AC, 60Hz. Dimensions: 50x45x25 cm. Software-controlled parameters.

Indications for Use

Indicated for dermatologic/general surgery procedures including vascular/pigmented lesion treatment, tattoo removal, hair reduction, skin resurfacing, acne scar/wrinkle treatment, and soft tissue coagulation/ablation. Applicable to Fitzpatrick skin types I-VI (varies by handpiece).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 12, 2016 Bios S.r.l Mr. Riccardo Pisati Regulatory Affairs Via Guido Rossa, 10/12 Vimodrone, IT-20090 Milan Re: K153229 Trade/Device Name: Superbium Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, ONG, ONF Dated: March 21, 2016 Received: March 25, 2016 Dear Mr. Pisati: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K153229 Device Name Superbium Indications for Use (Describe) The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for: -treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins; -treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; -tattoos (significant reduction in the intensity of black and/or blue-black tattoos); verrucae, skin tags, seborrheic keratosis; - reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; - coagulation and hemostasis of soft tissue; -the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for: Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of: - Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas -Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis -Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques - Pigmented benign lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles; Perioral wrinkles; -Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. -Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of: -Incision, excision, ablation, vaporization of soft tissue. - Tattoo removal: Light blue; Yellow; Red; Green - Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi -Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi {3}------------------------------------------------ ### -Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques The 2940 nm Er:YAG Laser Module handpiece is indicated for: Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of: Laser skin resurfacing procedures for the tr A. Acne scars - Acne scars . . Wrinkles The 2940 nm Er: Yag Fractional tips are indicated for: Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. IPL 400-1200 run handpiece is indicated for: · The treatment of moderate inflammatory acne vulgaris. · The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). · The treatment of benign cutaneous lesions including warts, scars and striae. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. ·Use on all skin types (Fitzpatrick I-VI). IPL500-1200 nm handpiece is indicated for: · The treatment of moderate inflammatory acne (acne vulgaris). · The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6. 9, and 12 months after the completion of a treatment regime. •Use on Fitzpatrick skin types I-V. IPL 550-1200 nm handpiece is indicated for: · The treatment of moderate inflammatory acne Vulgans. · The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). - · The treatment of face and body vascular and pigmented lesions. · The treatment of cutaneous lesions, including scars and striae. · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI). {4}------------------------------------------------ IPL 580-1200 run handpiece is indicated for: · The treatment of moderate inflammatory acne vulgaris. · The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). · The treatment of face and body vascular and pigmented lesions. · The treatment of cutaneous lesions, including scars and striae. · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI). IPL 620-1200 nm handpiece is indicated for: · The treatment of tattoos. · The treatment of moderate inflammatory acne vulgaris. · The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait. · The treatment of cutaneous lesions including warts, scars and striae. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. : The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6. 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI), including tanned skin. IPL 755-1200 nm handpiece is indicated for: • The treatment of tattoos. · The treatment of moderate inflammatory acne vulgaris. · The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). · The treatment of cutaneous lesions including warts, scars and striae. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis. · The treatment of pseudofolliculitis barbae (PFB). · The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. ·Use on all skin types (Fitzpatrick I-VI), including tanned skin. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {5}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {6}------------------------------------------------ Bios s.r.l. rev.03 pag. 1 of 26 # Section 5 510(k) Summary #### SUBMITTER I. | Applicant Information | Bios s.r.l. | |-----------------------|------------------------------| | | Via Guido Rossa, 10/12 | | | 20090 Vimodrone (MI) – Italy | | Contact | Ing. Aldo Casalino | | Date Prepared | 3 November 2015 | | II. DEVICE | | | Device Trade Name | SUPERBIUM | |---------------------|----------------------------------------------------------------------------------------------------------| | Common Name | Medical Laser System | | Regulatory class | II | | Classification Name | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (21 CFR 878.4810) | Product Code GEX, ONG, ONF #### III. PREDICATE DEVICE | 510(k) Number | Pro Code | Trade Name | Applicant | |---------------|--------------------------------------------|------------------------------------------|----------------------------| | K072344 | GEX 21 CFR 878.4810<br>FTC 21 CFR 878.4630 | APL MEDICAL SYSTEM | BIOS | | K103664 | GEX, ONG<br>21 CFR § 878.4810 | ICON AESTHETIC SYSTEM | Palomar | | K072564 | GEX, FTC, HHR, LNK<br>21 CFR 878.4810 | HARMONY XL<br>MULTI APPLICATION PLATFORM | ALMA | | K150140 | GEX 21 CFR 878.4810 | DERMABLATE | ASCLEPION | | K111303 | GEX 21 CFR 878.4810 | OMNIMAX | SHARPLIGHT<br>TECHNOLOGIES | | K090195 | GEX 21 CFR 878.4810 | LUX 1540 | PALOMAR | #### IV. DEVICE DESCRIPTION The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body (as specified in detail in Section 4). The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable {7}------------------------------------------------ | 510(k) Premarket Notification | Bios s.r.l. | |-------------------------------|--------------| | SUPERBIUM | rev.03 | | Section V | pag. 2 of 26 | handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following handpieces are available: - 1) Handpiece Nd:Yag Laser contains a flash lamp excited source that emits at 1064nm, with 2 different modalities: long pulse (ms) and short pulse (us). The handpiece can be equipped with different spots and also with an optical fiber. A pointing laser helps to guide the operator during the treatment. With this laser it is possible to treat vascular lesions, pigmented lesions, tattoos, scars, soft tissue, hair removal treatments (long pulse) and pigmented and vascular lesions, wrinkles and podiatry (short pulse). This laser is class IV according to the Standard EN60825-1. - 2) Handpiece Nd: Yag Laser contains a flash lamp excited source that emits 1064 and 532 nm Qs (0-Switched). The pulse duration is very short (ns), typical characteristic of OS lasers. The handbiece can be equipped with different spots. A pointing laser helps to guide the operator during the treatment. The Qs laser is ideal for the treatment of vascular lesions, scars, pigmented lesions, skin resurfacing (1064 nm) and soft tissue, tattoo, vascular lesions, pigmented lesions (532 nm). This laser is class IV according to the Standard EN60825-1. - 3) Handpiece Erbium Laser contains a flash lamp excited source that emits at 2940 nm. The handpiece can be equipped with different spots; two of them are fractional, so they divide the shot in several microbeams. The Er:Yag laser is ideal for soft tissue, skin resurfacing, skin lesions treatments. This laser is class IV according to the Standard EN60825-1. - 4) Handpiece Erbium Glass Laser contains a flash lamp excited source that emits at 1540 mm. The handpiece can be equipped with two spots, both fractional, that divide the shot in several microbeams. The Er:Glass is ideal for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue, for example scar treatments. This laser is class IV according to the Standard EN60825-1. - 5) Handpiece Pulsed Light contains a xenon lamp that emits from 400 and 1200 nm. On this handpiece it is possible to change easily the guide light, equipped with a specific light filter and to use thus that one most adequate for the individual photo type. It is possible also to have a cooling for the guides, as optional. With the use of this handpiece is possible to perform pigmented lesions, scars, vascular lesions, tattoos, hair removal. {8}------------------------------------------------ | 510(k) Premarket Notification | Bios s.r.l. | |-------------------------------|--------------| | SUPERBIUM | rev.03 | | Section V | pag. 3 of 26 | #### V. Indication for Use The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for: - treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; - treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; - tattoos (significant reduction in the intensity of black and/or blue-black tattoos); verrucae, skin tags, seborrheic keratosis; - reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar: - coagulation and hemostasis of soft tissue; - the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for: Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of: - Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas - Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis - Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafè-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles; Perioral wrinkles; - Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of: - Incision, excision, ablation, vaporization of soft tissue. - Tattoo removal: Light blue; Yellow; Red; Green - Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi {9}------------------------------------------------ | 510(k) Premarket Notification | Bios s.r.l. | |-------------------------------|--------------| | SUPERBIUM | rev.03 | | Section V | pag. 4 of 26 | - Benign pigmented lesions: Cafè-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi - Other pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques The 2940 nm Er: Y AG Laser Module handpiece is indicated for: Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of: - Acne scars ● - . Wrinkles The 2940 nm Er: Yag Fractional tips are indicated for: Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: glands) such as, but not limited to: Dermatology and plastia Surgery Skin ros Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia: Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. IPL 400-1200 run handpiece is indicated for: · The treatment of moderate inflanunatory acne vulgaris. · The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, inelasma, and ephelides (freckles). · The treatment of cutaneous lesions including warts, scars and striae. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. ·Use on all skin types (Fitzpatrick I-VI). IPL500-1200 nm handpiece is indicated for: · The treatment of moderate inflanunatory acne (acne vulgaris). · The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte. leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defmed as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. ·Use on Fitzpatrick skin types I-V. IPL 550-1200 nm handpiece is indicated for: {10}------------------------------------------------ | 510(k) Premarket Notification | Bios s.r.l. | |-------------------------------|--------------| | SUPERBIUM | rev.03 | | Section V | pag. 5 of 26 | · The treatment of moderate mtlammatory acne VUlgans. · The treatment of benign pigmented epidermal lesions, includiog dyschromia, hyperpigmentation, melasma and ephelides (freckles). · The treatment of face and body vascular and pigmented lesions. · The treatment of cutaneous lesions, includiog scars and striae. · The treatment of benign cutaneous vascular lesions, includiog port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veios and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI). IPL 580-1200 run handpiece is indicated for: · The treatment of moderate inflammatory acne vulgaris. · The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). · The treatment of face and body vascular and pigmented lesions. · The treatment of cutaneous lesions, including scars and striae. · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI). IPL 620-1200 nm handpiece is iodicated for: · The treatment of tattoos. · The treatment of moderate inflammatory acne vulgaris. · The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpiementation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and ca!e-au-lait. · The treatment of cutaneous lesions including warts, scars and striae. · The treatment of benign cutaneous vascular lesions includiog port wine stains, hemangiomas, facial. truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. : The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction io the number of hairs regrowiog when measured at 6, 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI), iocludiog tanned skin. IPL 755-1200 nm handpiece is indicated for: · The treatment of tattoos. · The treatment of moderate ioflammatory acne vulgaris. · The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpigmentation, melasma, and ephelides (freckles). {11}------------------------------------------------ | 510(k) Premarket Notification | Bios s.r.l. | |-------------------------------|--------------| | SUPERBIUM | rev.03 | | Section V | pag. 6 of 26 | · The treatment of cutaneous lesions iocluding warts, scars and striae. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis. · The treatment of pseudofolliculitis barbae (PFB). · The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. · Use on all skin types (Fitzpatrick I-VI), including tanned skin. {12}------------------------------------------------ #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES By comparing SUPERBIUM to the legally marketed predicate devices, it is substantially equivalent in terms of intended use and utilizes similar functional features including energy source, frequency, fluency, pulse width. The general features of SUPERBIUM are similar to those of the predicates in particular as regards the classification IV laser, the equipment of a the cooling system and the electrical specifications. Also the predicate devices are equipped with a touch screen and with a control SW. The intended use of each handpiece of SUPERBIUM are identical to those of the handpieces of the predicates and also the technical characteristics are the same, in particular: - handpiece Nd:Yag Long Pulse of SUPERBIUM with the wavelength of 1064 nm applies an output power and a maximum energy per pulse operating in the same range of Harmony XL K072564 and the Icon Aesthetic System K103664. The emission frequency of the handpiece Nd:Yag Long Pulse of SUPERBIUM is the same of Harmony XL K072564 and it is in the same interval the Icon Aesthetic System K103664. - handpiece Nd:Yag Short Pulse of SUPERBIUM with the wavelength of 1064 nm applies an output power and a maximum energy per pulse operating, in the same range of APL Medical System K072344. - handpiece Nd:YAG Q-Switched of SUPERBIUM with a wavelength of 1064+532 nm applies a maximum output power and a maximum energy per pulse similar to those of the Harmony XL K072564. The pulse duration is in the same range of predicates and fluence value is similar to that of the Harmony XL K072564. The emission frequency of the handpiece Nd: YAG Q-Switched of SUPERBIUM is the same of predicates. - handpiece Er.Yag of SUPERBIUM with a wavelength of 2940 nm applies a maximum output power in the same range of values APL Medical System K072344 and of the Dermablate K150140 and a maximum energy per pulse that is the same value of Dermablate K150140. The value of the fluence the same to predicate devices Dermablate K150140 for the same spot size. The emission frequency of the handpiece Er: Yag of SUPERBIUM is similar to that of the Dermablate K150140. {13}------------------------------------------------ - handpiece Er:Yag Fractional Tip of SUPERBIUM is equal to the predicate SHARPLIGHT - TECHNOLOGIES OMNIMAX K1113603. The numbers of dots are the same, and also the fluencies are very similar. The frequency emission is the same. - handpiece Er:Yag Glass of SUPERBIUM with a wavelength of 1540 nm is equal to the predicate -Palomar LUX 540 K090195. In particular they have same parameters for max energy, dot density and consequently the fluence parameters are the same. Also the pulse duration and the emission frequency are equal to the predicate. - the IPL handpiece of SUPERBIUM has the same emission spectrum (400 1200 nm) of the Harmony XL K072564 and of APL Medical System K072344. The standard filters equipment is the same and also the maximum energy per pulse is in the same range of mentioned predicates. The maximum fluence valueis the same and the values of the maximum pulse duration and frequency are similar. {14}------------------------------------------------ Base: 50x54x38 Dimensions (LxPxH) cm 50x45x25 cm #### Section V - | A) General Features | | | | | | | | | |--------------------------------------|----------------|-----------------------------------------------|--------------------------------------------|--------------------------------------|---------------------------------------|---------------------------|----------------------------|-----------------------| | Device<br>Basic<br>Technical<br>Data | Applicant | BIOS | BIOS | Palomar | ALMA | ASCLEPION | SHARPLIGHT<br>TECHNOLOGIES | PALOMAR | | | Device Name | SUPERBIUM | APL MEDICAL<br>SYSTEM | ICON AESTHETIC<br>SYSTEM | HARMONY XL | DERMABLATE | OMNIMAX | LUX 1540<br>Handpiece | | | 510k | --- | K072344 | K103664 | K072564 | K150140 | K111303 | K090195 | | | Classification | GEX 21 CFR<br>878.4810,<br>ONF 21CFR 878.4810 | GEX 21 CFR 878.4810<br>FTC 21 CFR 878.4630 | GEX, ONG<br>21 CFR § 878.4810 | GEX, FTC, HHR, LNK<br>21 CFR 878.4810 | GEX<br>878.4810 | GEX<br>878.4810 | GEX<br>878.4810 | | Intended Use | | Nd:Yag Handpiece<br>LP | See Table B | See Table B | See Table B | - | - | - | | | | Nd:Yag Handpiece<br>SP | See Table C | - | - | - | - | - | | | | Nd:Yag Q-Switched<br>Handpiece | See Table D | - | See Table D | - | - | - | | | | Er:Yag Handpiece | See Table E | - | - | See Table E | - | - | | | | Er:Yag Handpiece<br>Fractional | - | - | - | - | See Table F | - | | | | Er:Yag Glass<br>Handpiece | - | - | - | - | - | See Table G | | | | IPL Handpiece | See Table H | - | See Table H | - | - | - | | Display | | Display LCD 10.4"<br>touch screen. | LCD Color Display<br>"touch screen". | LCD Color Display<br>"touch screen". | LCD Color display<br>"touch screen" | Display "touch<br>screen" | Display "touch<br>screen" | - | | Voltage | | 110V Ac ±10% | 110V Ac ±10% | 90 - 264 VAC | 100 -120 VAC | 110V Ac | 100-240 V | - | | Frequency | | 60 Hz ± 1% | 60 Hz ± 1% | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz | 50-60Hz, | - | | Absorbed power | | 12A (average)— 24A<br>max | 8A (average)—<br>12,5A max | 20 A | 20 A | 500 VA | max 1-A | - | | Cooling system | | YES | YES | YES | YES | YES | YES | - | | Laser class | | IV | IV | IV | IV | IV | IV | IV | | Weight | | 35 Kg | Approx 21 Kg | 47.17 Kg | Upper Unit 15 kg,<br>Lower Unit 45 kg | 75 Kg | 70kg | - | 58x54x103 cm 39.7 x 55 x 123 cm 36 x 60 x 93 cm 56 x 42 x 105 cm {15}------------------------------------------------ # B)Nd:Yag Handpiece Long Pulse | Applicant | BIOS | BIOS | ALMA | PALOMAR | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | SUPERBIUM | APL MEDICAL<br>SYSTEM | HARMONY XL | ICON AESTHETIC SYSTEM | | 510k | --- | K072344 | K072564 | K103664 | | Classification | GEX 21 CFR 878.4810, ONF | GEX, FTC | GEX, FTC, HHR, LNK | GEX, ONG | | Laser source | Nd:YAG LP | Nd:YAG LP | Nd:Yag LP | Nd:Yag | | Wavelenght | 1064 nm | 1064 nm | 1064 nm | 1064 nm | | Output power | 45W max | 20W max | 40W max | 50 W | | Max energy per pulse | LP: 45J (max) | LP: 20J (max) | 40 J | 50 J | | Beam diameter (spot) | 1, 2, 3, 4, 5, 6, 9, 11,12,13,14,15 mm | 2; 5 mm | 6 mm | 1,5; 3; 6; 10 mm | | Fluence | 500J/cm2 (max);<br>3 mm: 500J/cm2 (max);<br>6 mm: 160 J/cm2 | 285 J/cm2 (spot<br>3mm) | 30-450 J/cm2 (2);<br>30-150 J/cm2 (6);<br>30-450 J/cm2 (10) | 1,5 mm - 250/750 J/cm2;<br>3 mm - 70/450 J/cm2;<br>6 mm - 16/140 J/cm2;<br>10 mm - 7/50 J/cm2 | | Pulse duration | LP: 1 - 25 ms | LP: 5 - 25 ms | 8-15ms (2);<br>40-60 ms (6);<br>15 ms (10) | 10 - 100 ms | | Emission frequency | LP: 1 Hz (max) | LP: 1 Hz (max) | 1 Hz | 0,2 - 2 Hz | | Intended Use | The Nd:Yag 1064 Laser Handpiece<br>(Long Pulsed) is intended for: | | 1064 nm Long Pulsed Module<br>Handpieces<br>The 1064 nm Nd:YAG Laser Module<br>handpieces (Long Pulsed and Q-<br>Switched with and without contact-<br>cooling) are indicated for treatment<br>and clearance of: | The 1064 Laser Handpiece is<br>intended for | | | treatment of vascular lesions<br>such as but not limited to, port<br>wine stains, hemangiomas,<br>telangiectasias, rosacea, venus<br>lake, facial and leg veins; | 6. treatment of<br>capillaries,<br>teleangiectasies and<br>vascular lesions (LP) | • Benign vascular lesions such as,<br>but not limited to treatment of:<br>Port wine stains; Hemangiomas;<br>Warts; Superficial and deep<br>telangiectasias (venulectasias);<br>Reticular veins (0.1-4.0 mm dia.) of<br>the leg; Rosacea; Venus lake; Leg<br>veins; Spider veins; Poikiloderma of<br>Civatte; Angiomas | treatment of vascular lesions<br>such as but not limited to,<br>port wine stains,<br>hemangiomas,<br>telangiectasias, rosacea,<br>venus lake, facial and leg<br>veins; | | Applicant | BIOS | BIOS | ALMA | PALOMAR | | | SUPERBIUM | APL MEDICAL SYSTEM | | | | Device Name | | | HARMONY XL | ICON AESTHETIC SYSTEM | | 510k | --- | K072344 | K072564 | K103664 | | | treatment of benign pigmented<br>lesions such as, but not limited<br>to, senile lentigines (age spots),<br>solar lentigos (sun spots),<br>pigmented seborrheic<br>keratoses, nevi, chloasma, cafe-<br>au-lait macules, and plaques; | | • Benign cutaneous lesions, such as,<br>but not limited to:<br>Warts; Scars; Striae; Psoriasis | treatment of benign<br>pigmented lesions such as,<br>but not limited to, senile<br>lentigines (age spots), solar<br>lentigos (sun spots),<br>pigmented seborrheic<br>keratoses, nevi, chloasma,<br>cafe-au-lait macules, and<br>plaques; | | | tattoos (significant reduction in<br>the intensity of black and/or<br>blue-black tattoos);<br>verrucae, skin tags, seborrheic<br>keratosis; | | • Benign pigmented lesions such as,<br>but not limited to:<br>Lentigos (age spots); Solar lentigos<br>(sun spots); Cafè-au-lait macules;<br>Seborrheic keratoses; Nevi and<br>nevus of Ota; Chloasma; Verrucae;<br>Skin tags; Keratoses; The removal of<br>black, blue or green tattoos<br>(significant reduction in the<br>intensity of black and /or blue/black<br>tattoos); Plaques | tattoos (significant reduction<br>in the intensity of black<br>and/or blue-black tattoos);<br>verrucae, skin tags,<br>seborrheic keratosis; | | | reduction of red pigmentation<br>in hypertrophic and keloid scars<br>where vascularity is an integral<br>part of the scar; | | Laser skin resurfacing procedures<br>for the treatment of:<br>Acne scars; Wrinkles | reduction of red<br>pigmentation in hypertrophic<br>and keloid scars where<br>vascularity is an integral part<br>of the scar; | | | coagulation and hemostasis of<br>soft tissue; | | Reduction of red pigmentation in<br>hypertrophic and keloid scars where<br>vascularity is an integral part of the<br>scar. | coagulation and hemostasis<br>of soft tissue; | | Section V | | | pag. 12 of 26 | | | Applicant | BIOS | BIOS | ALMA | PALOMAR | | Device Name | SUPERBIUM | APL MEDICAL<br>SYSTEM | HARMONY XL | ICON AESTHETIC SYSTEM | | 510k | --- | K072344 | K072564 | K103664 | | | the removal of unwanted hair<br>for skin types I-VI, and to effect<br>stable long-term permanent<br>hair reduction; | 1. The removal of<br>unwanted hair and<br>to effect stable long-<br>term or permanent<br>hair reduction (LP) | 1064 nm Long Pulsed Only Nd:YAG<br>Laser Module Handpieces<br>The 1064 nm Nd:YAG lasers (Long<br>Pulsed only, with and without<br>contact-cooling) is indicated for:<br>- Removal of unwanted hair, for<br>stable long-term, or permanent,<br>hair reduction through selective<br>targeting of melanin in hair follicles.<br>- Removal or lightening of unwanted<br>hair (with and without adjuvant<br>preparation)<br>- Treatment of pseudofolliculitis<br>barbae (PFB)<br>- Indicated for use on all skin types<br>(Fitzpatrick I-VI), including tanned | the removal of unwanted hair<br>for skin types I-VI, and to<br>effect stable long-term<br>permanent hair reduction | {16}------------------------------------------------ # Section V ### Bios s.r.l. rev.03 {17}------------------------------------------------ ### Section V # Bios s.r.l. rev.03 {18}------------------------------------------------ Bios s.r.l. rev.03 pag. 13 of 26 # C)Nd:Yag Handpiece - Short Pulse | Applicant | BIOS | BIOS | Applicant | BIOS | BIOS | ALMA | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | SUPERBIUM | APL MEDICAL SYSTEM | Device Name | SUPERBIUM | APL MEDICAL<br>SYSTEM | HARMONY XL | | 510k | --- | K072344 | 510k | ---…
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