Who is the manufacturer of mJOULE System and Accessories?

Sciton, Inc filed the 510(k) submission for mJOULE System and Accessories (K213350).

What is the FDA product code for mJOULE System and Accessories?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for mJOULE System and Accessories?

510(k) clearance (submission type: Traditional).

What are the predicate devices for mJOULE System and Accessories?

Quanta System Discovery Pico Family (K191842); Fotona Dynamis Pro Family (K182088); Sciton Profile 1064 Laser System and Accessories (K023881).

Who can help prepare an FDA 510(k) submission like mJOULE System and Accessories?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

mJOULE System and Accessories

K213350 · Sciton, Inc · GEX · Apr 15, 2022 · General, Plastic Surgery

Device Facts

Record ID	K213350
Device Name	mJOULE System and Accessories
Applicant	Sciton, Inc
Product Code	GEX · General, Plastic Surgery
Decision Date	Apr 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The mJOULE 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJOULE 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The mJOULE 1064 laser system and accessories is indicated for the treatment of facial wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). Laser assisted lipolysis. Treatment of mild to moderate inflammatory acne vulgaris. Surgical Applications: Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.

Device Story

mJOULE 1064nm laser system consists of a console, power supply, cooling system, and fiber/arm delivery system with handpieces. Device delivers optical energy to tissue via focusing optics; user activates emission via footswitch. Used in clinical settings by physicians for surgical and aesthetic applications. System provides coagulation, hemostasis, ablation, and vaporization of soft tissue. Output allows for treatment of vascular/pigmented lesions, hair reduction, and various surgical procedures. Healthcare providers use the touch screen interface to set parameters; output affects tissue directly via thermal energy. Benefits include precise tissue management and aesthetic improvement.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), and laser safety (IEC 60601-2-22, IEC 60825-1). Biocompatibility of the ClearV handpiece sapphire window and gold frame was evaluated per ISO 10993-1. No clinical data provided.

Technological Characteristics

Class 4 Nd:YAG laser (1064 nm). Features microprocessor control, touch screen interface, water-to-air cooling, and fiber/arm delivery. Pulse duration 0.1-300 ms, repetition rate up to 20 Hz, fluence up to 400 J/cm². Safety features include remote interlock and aiming beam (650 nm). Biocompatibility per ISO 10993-1 for tissue-contacting components.

Indications for Use

Indicated for patients requiring surgical or aesthetic laser treatment across multiple specialties including dermatology, general/plastic surgery, ENT, gynecology, and urology. Treats benign vascular/pigmented lesions, hypertrophic/keloid scars, unwanted hair (all Fitzpatrick types I-VI), facial wrinkles, onychomycosis, aphthous ulcers, herpes simplex, acne vulgaris, and performs soft tissue incision/ablation/coagulation.

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

Quanta System Discovery Pico Family (K191842)
Fotona Dynamis Pro Family (K182088)
Sciton Profile 1064 Laser System and Accessories (K023881)

Related Devices

K014040 — FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS · Altus Medical, Inc. · Jun 3, 2002
K070388 — PROFILE MULTI-PLATFORM SYSTEM · Sciton, Inc · May 2, 2007
K122567 — JOULE 810/940/980 MULTI-PLATFORM SYSTEM · Sciton, Inc · Jun 19, 2013
K120235 — MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP · Aerolase Medical Lasers, LLC · Sep 17, 2012
K101916 — JOULE MULTI-PLATFORM SYSTEM · Sciton, Inc · Mar 18, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 15, 2022 Sciton, Inc Jay Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303 Re: K213350 Trade/Device Name: mJOULE System and Accessories 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 Dated: March 14, 2022 Received: March 17, 2022 Dear Jay Patel: 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. {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213350 Device Name mJOULE System and Accessories ### Indications for Use (Describe) The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for pigmented 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term. or permanent hair reduction through selective of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). Laser assisted lipolysis. Treatment of mild to moderate inflammatory acne vulgaris. Surgical Applications: Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary K213350 | Submitter: | Sciton, Inc. | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 925 Commercial Street, Palo Alto, CA 94303 | | Phone: | (650) 493-9155 | | Fax: | (650) 493-9146 | | Contact Person: | Jay M. Patel, VP of Regulatory Affairs | | Date Prepared: | October 4, 2021 | | Device Trade Name: | mJOULE System | | Common Name: | Laser Powered Surgical Device (and Accessories) | | Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. | | Classification Product Code: | GEX | | Legally Marketed Predicate Device: | K191842 Quanta System Discovery Pico Family K182088 Fotona Dynamis Pro Family K023881 Sciton Profile 1064 Laser System and Accessories | | Description of the mJOULE 1064 nm Laser System: | The mJOULE 1064nm Laser System consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, fiber arm delivery system with a handpiece. The user activates laser emission by means of a footswitch. | | Indications for Use: | The mJOULE 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJOULE 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The mJOULE 1064 laser system and accessories is indicated for the treatment of facial wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). | | | Laser assisted lipolysis. Treatment of mild to moderate inflammatory acne vulgaris. | | | Surgical Applications: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology. | | Technological Characteristics: | The mJOULE System shares the same indications for use, and as noted below, shares similar design features (including wavelength, laser medium and delivery systems, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence), and is therefore substantially equivalent to the above legally marketed predicate devices. | {5}------------------------------------------------ {6}------------------------------------------------ Comparative representation of the Quanta System Discovery Pico Family (K191842), the Fotona Dynamis Pro Family (K182088), the Sciton Profile 1064 Laser System and Accessories (K023881) which are the predicate for the newly submitted device (mJOULE 1064 Laser system and Acce | Specification | Predicate Device | Primary Predicate Device | Predicate Device | This Application | Substantially Equivalent | | |---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|-----------------------------|--| | 510(k) Number | K191842 | K182088 | K023881 | N/A | -- | | | Product | Quanta System Discovery Pico Family | Fotona Dynamis Pro Family | Sciton Profile 1064 Laser System and Accessories | mJOULE 1064 Laser System and Accessories | -- | | | Regulation | GEX, 21 CFR 878- 4810 | GEX, 21 CFR 878- 4810 | GEX, 21 CFR 878- 4810 | GEX, 21 CFR 878- 4810 | Yes | | | CDRH Laser Class | Class 4 | Class 4 | Class 4 | Class 4 | Yes | | | Energy Source | Nd: YAG, and Ruby | Nd: YAG | Nd: YAG | Nd: YAG | Yes | | | Device Class | ll | ll | ll | 11 | Yes | | | Laser Wavelength (nm) | 1064 | 1064 | 1064 | 1064 | Yes | | | Maximum Repetition Rate | Up to 10 Hz | Up to 100 Hz | 15 Hz | 20 Hz | Yes | | | Pulse Duration | 0.3 - 50 ms | 0.1 - 50 ms | 0.1 - 300 ms | 0.1 - 300 ms | Yes | | | Spot Size | 2 to 8 mm | 3 – 9 mm | 0.5 – 15 mm | 0.5 – 15 mm | Yes | | | Fluence | Up to 300 joules/cm² | Up to 300 joules/cm² | Up to 400 joules/cm² | Up to 400 joules/cm² | Yes | | | Utilities | 200-240 VAC, 50/60 Hz | 100-240 VAC | 230 VAC, 50/60 Hz | 230 VAC, 50/60 Hz | Yes | | | Aiming Beam | 650 nm (red) | 635 nm/650 nm (red) or 520-535 nm (green); <1 mW | 650 nm (red); <1 mW | 650 nm (red); <1 mW | Yes | | | Delivery System | Fiber/Arm | Fiber | Arm | Fiber/Arm | Yes | | | Handpiece | Single spot or scanner | Single spot or scanner | Single spot or scanner | Single spot or scanner | Yes | | | Power (Watts) | N/A | Up to 80 W | 50 W | 50 W | Yes | | | Cooling System | Water to Air | Water to Air | Water to Air | Water to Air | Yes | | | Control System | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes | | | Energy Monitor | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Yes | | | Safety | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Yes | | | Console Dimension | 20.8" x 41" x 42" | N/A | 14" x 21" x 41" | 12" x 15" x 43" | Yes | | | User Interface | Touch screen control | Touch screen control | Touch screen control | Touch screen control | Yes | | | Indications for Use | See section 1.1 | See section 1.2 | See section 1.3 | See section 1.4 | Yes | | | Note: The IFU for K191842 and K182088 mentioned in this table is not the complete IFU but only the IFU related to the YAG 1064 nm laser. | | | | | | | {7}------------------------------------------------ #### Section 1.1 (K191842) Removal of unwanted hair. for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Photocoaqulation and hemostasis of benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasia, rosacea, Venus Lake, leg veins and Spider veins. Coagulation and hemostasis of soft tissue. Treatment of wrinkles. Treatment of mild to moderate inflammatory acne vulgaris. #### Section 1.2 (K182088) The Dynamic Nd: YAG laser is intended for incision, ablation, vaporization and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. Surgical incision, excision, vaporization, ablation and coagulation of soft tissue is included, striated and smooth tissue, muscle, cartilage, membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy. Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). Laser assisted lipolysis. Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatick 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 wrinkles. Treatment of wrinkles with S11 scanner. Treatment of mild to moderate inflammatory acne vulgaris. Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangioma, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. Podiatry (ablation, vaporization, incision, 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., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities. {8}------------------------------------------------ #### Section 1.3 (K023881) The 1064 laser system and accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolarynqology (ENT), neurosurgery, oculoplastic, pulmonarythoracic surgery and urology for surgical and aesthetic applications. #### Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus Lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to. lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The Profile 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 laser system and accessories is indicated for the treatment of facial wrinkles. The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. #### Surgical Applications: Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology. {9}------------------------------------------------ #### Section 1.4 (this application) The mJOULE 1064 laser systems and accessories is intended for use in the medical special and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolarynqology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. #### Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to. lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJOULE 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The mJOULE 1064 laser system and accessories is indicated for the treatment of facial wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.q., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). Laser assisted lipolysis. Treatment of mild to moderate inflammatory acne vulgaris. Surgical Applications: Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology. | Safety and Effectiveness | The indications for use are based upon the indications for use for predicate systems. Technologically, the mJOULE System is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the mJOULE System is comparable to the predicate devices. | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Non-clinical Tests: | Performance: FDA recognized consensus standards were utilized to evaluate the mJOULE system for non-clinical performance. These included electrical, mechanic EMC testing, usability and essential performance of the mJOULE system. IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 applicable for the general requirements concerning basic safety and essential performance that are applicable to medical electrical equipment. Examples of tests performed on the mJOULE system based upon this standard are power input, humidity, durability of markings, leakage current, dielectric strength, excessive temperature, push & impact tests, etc. IEC 60601-1-2: 2014 indicates the conformity of the mJOULE system to the basic safety and essential performance of medical equipment (ME) in the presence of electromagnetic disturbance and for electromagnetic emission of ME systems. Examples of the tests performed are electrostatic discharge immunity test, electromagnetic field immunity, transient immunity, power frequency magnetic field immunity, voltage dips/interruptions immunity tests, etc. | {10}------------------------------------------------ - . IEC 60601-1-6: 2010, AMD:2013 indicates the usability of mJOULE system and its associated accessories. Examples of evaluations performed are usability of engineering principles, hazards related to usability, user interface, medical benefits versus risks, etc. - . IEC 60601-2-22: 2007(Third edition) +A1:2012 for use in conjunction with IEC 60601-1:2005 (Third edition) + A1:2012 indicates the conformity of mJOULE system with the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnose laser equipment. Examples of test performed are: Interruption of power supply, indication of laser output, indications of parameters relevant to safety and emergency stop. - . IEC 60825-1: 2014 (Third edition) applicable for the safety of mJOULE system and its delivery accessories. An Examples of test performed is: Determination of accessible emission levels. Biocompatibility: The biocompatibility is not applicable for mJOULE ClearSilk delivery system since there is no tissue contacting component for its indications. ClearV handpiece application in treating the vascular lesions is however a tissue contacting component in the mJOULE system. The skin touching surface of the ClearV handpiece for the vascular lesion treatment is a gold framed sapphire window spacer that provide cooling to the skin. The biocompatibility evaluation of the sapphire window and the gold frame in the ClearV handpiece was conducted in accordance with the international standard ISO-10993-1 "Biological evaluation of medical devices-part1: evaluation and testing within a risk management process." As identified by FDA (See attachment VI). Software: Software verification and validation testing documents are provided in attachment VII of the document as recommended by "Guidance for the content of premarket submissions for software contained in medical devices." Considered as "Moderate" level of concern. All the items in the software risk analysis, software development procedure, cybersecurity risk analysis, software requirement specification, software design documentation, software test plan and traceability analysis met the requirements. Sterility: The mJOULE system has no component or accessory that is sold sterile. Shelf-life: Shelf-life is not applicable for mJOULE system because of low likelihood of time-dependent product degradation. The conclusions drawn from the non-clinical tests demonstrate that the mJOULE Conclusion: system is safe and effective, and performs as well as or better than the legally marketed device predicate.