Vydence Laser Family

K190007 · Vydence Medical Industria E Comercio Ltda · GEX · Mar 1, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190007
• Device Name: Vydence Laser Family
• Applicant: Vydence Medical Industria E Comercio Ltda
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Vydence Laser Family is indicated for a wide range of dermatological and surgical procedures depending on the specific handpiece and wavelength used. IPL filters (400-1200nm, 515-1200nm, 540-1200nm, 580-1200nm, 640-1200nm, 695-1200nm) are indicated for the treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides, lentigines, nevi, cafe-au-lait macules), benign cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, Poikiloderma of Civatte, leg veins, venous malformations), tattoo removal, and stable long-term or permanent hair reduction on various Fitzpatrick skin types (I-VI). The Intense IR Handpiece is indicated for topical heating, temporary relief of minor muscle/joint pain and stiffness, temporary increase in local circulation, and muscle relaxation. The 1064nm Long Pulse Handpiece is indicated for hair reduction, PFB, benign vascular lesions, benign pigmented lesions, benign cutaneous lesions, non-ablative treatment of facial wrinkles, laser skin resurfacing, reduction of red pigmentation in scars, and podiatry applications including onychomycosis. The Acroma Handpiece (1064nm) is indicated for benign vascular lesions, benign cutaneous lesions, benign pigmented lesions, tattoo removal, non-ablative facial wrinkle treatment, and laser skin resurfacing. The 532nm wavelength is indicated for soft tissue incision/excision/ablation/vaporization, tattoo removal, benign vascular lesions, and benign pigmented lesions. The 1540 GoSmooth Handpiece is indicated for coagulation of soft tissue, skin resurfacing, and treatment of melasma, striae, and scars. The 2940 DualMode Handpiece is indicated for skin resurfacing, wrinkle treatment, and various dermatological/podiatric lesions. The 1340 ProDeep Handpiece is indicated for skin resurfacing. The 755nm Fiber Delivered Handpiece is indicated for hair reduction, benign pigmented lesions, wrinkles, and vascular lesions. The 1064nm Fiber Delivered Handpiece is indicated for vascular lesions, non-ablative wrinkle treatment, hair reduction, PFB, and onychomycosis.

Device Story

Vydence Laser Family consists of multi-wavelength laser and IPL system with interchangeable handpieces; delivers light energy (IPL, 532nm, 755nm, 1064nm, 1340nm, 1540nm, 2940nm) to target tissue; used by physicians in clinical settings for dermatological, plastic surgery, and podiatric applications; system transforms electrical energy into specific optical wavelengths; output used for coagulation, ablation, vaporization, or photothermolysis of target lesions; clinical decision-making guided by visual assessment of skin/lesion type; benefits include non-invasive or minimally invasive treatment of aesthetic and medical skin conditions; includes specialized modes like DYNAMICS for onychomycosis and fractional modes for resurfacing.

Clinical Evidence

Bench testing only. No clinical data provided in the summary.

Technological Characteristics

Multi-platform laser and IPL system; wavelengths include 532nm, 755nm, 1064nm, 1340nm, 1540nm, 2940nm and IPL (400-1200nm range); energy delivery via fiber-delivered or direct-contact handpieces; includes fractional and long-pulse modes; cooling systems integrated for skin protection; system is standalone; sterilization via standard clinical protocols for reusable handpieces.

Indications for Use

Indicated for patients requiring dermatological, plastic surgery, or podiatric procedures including hair reduction, vascular/pigmented lesion treatment, skin resurfacing, wrinkle reduction, scar/striae treatment, acne vulgaris management, tattoo removal, and temporary pain relief. Applicable to Fitzpatrick skin types I-VI depending on the specific wavelength/handpiece. Contraindications not explicitly listed beyond standard laser safety precautions.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vydence Medical Industria E Comercio Ltda % Kathy Maynor Vydence Regulatory Consultant Vydence Medical 26 Rebecca Ct. Homosassa, Florida 34446

March 1, 2019

# Re: K190007

Trade/Device Name: Vydence Laser Family 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, PDZ, ONF Dated: December 30, 2018 Received: January 2, 2019

Dear Kathy Maynor:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by Neil R Neil R Ogden -S Date: 2019.03.01 Oaden -S 15:35:30 -05'00'

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

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# Indications for Use

510(k) Number (if known)

# K190007

Device Name Vydence Laser Family

Indications for Use (Describe)

· IPL 400nm-1200nm Filter

· 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).

IPL 515-1200nm Filter

· The treatment of moderate inflammatory acne (acne vulgaris).

· The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafè-aulait 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 Civate, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime.

· Use on Fitzpatrick skin types I-V.

### IPL 540nm-1200nm Filter

· benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),

· lentigines, nevi, 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 Civate, leg veins and venous malformations.

· The treatment of benign cutaneous lesions including warts, scars and striae.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth 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 540nm-1200nm Filter

· benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),

· lentigines, nevi, 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

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venous malformations.

· The treatment of benign cutaneous lesions including warts, scars and striae.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth 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 580nm-1200nm Filter

· 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 benign vascular and benign pigmented lesions.

· The treatment of benign 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 growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

#### IPL 640nm-1200nm Filter

· the treatment of tattoos;

· The treatment of mild to moderate inflammatory and pustular 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 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 Civate, leg veins and venous malformations;

· removal of unwanted hair, for stable long term or permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regimen).

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.

#### IPL 695nm-1200nm Filter

· removal of unwanted hair, for stable long term or permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen).

• Use on all skin types (Fitzpatrick I-VI), including tanned skin

#### Intense IR Handpiece

· intended to emit energy in the infrared spectrum to provide topical heating for the tissue temperature. It's also indicated for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor strains, and minor muscular back pain.

1064nm Long Pulse Handpiece

· removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin tvpes, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime:

· Treatment of pseudofolliculitis barbae (PFB)

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· 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 Spider veins; Poikiloderma of Civatte; Angiomas

· Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Sebortheic 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

· Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis

- · 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
- · 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;

# 1064nm Long Pulse Handpiece - Short Pulse Operation

· intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosaceal diffiuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts.

- · is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
- · For use on all skin types (Fitzpatrick I-VI), including tanned skin.

1064nm Long Pulse Handpiece - Onychomycosis

· podiatry (i.e. ablation, vaporization, excision, and coagulation of soft tissue) including matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas,

· temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).

### Acroma Handpiece

The 1064 nm wavelength is indicated for:

· treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; 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 (sun lentigos (sun spots); cafe-au-lait macules; sebortheic 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 lesions' 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, including but not limited to: periocular 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 532 nm wavelength is indicated for:

- · incision, excision, ablation, vaporization of soft tissue;
- · tattoo removal: light blue, yellow, red; green;

· benign vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas (cherry, spider); telangiectasias; 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

# 1540 GoSmooth Handpiece

· The 1540 Fractional Non-ablative Laser Handed for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

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# 2940 DualMode Handpiece · DERMATOLOGY AND PLASTIC SURGERY

Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins;

Actinic chelitis; Keloids; Verrucae; Skin tags; Keratose; Scar revision (including acne scars); Debulking benign tumors; Debulking cysts; Superficial skin lesions; Diagnostic biopsies; Decubitus ulcers; · PODIATRY

Treatment of: Warts, plantar verrucae, large mosaic verrucae. Matrixectomy.

2940 DualMode - fractional - skin resurfacing

1340 ProDeep Handpiece · non-ablative laser handpiece is intended for use in skin resurfacing

755nm Fiber Delivered Handpiece (Zye and One)

755nm

• Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime; treatment of benign pigmented lesions; treatment of wrinkles; photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias.

# 1064nm Fiber Delivered Handpiece (Zye and One)

In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lessons and epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of facial wrinkles and for removal of unwanted hair, for stable long term or permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-V), including tanned skin.

· In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).

| Type of Use (Select one or both, as applicable) | |
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X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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