HandPICO

K220041 · Vydence Medical Industria E Comercio Ltda · GEX · May 5, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220041
• Device Name: HandPICO
• Applicant: Vydence Medical Industria E Comercio Ltda
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vydence Laser Family (Addition of HandPICO Handpiece) is intended for use in dermatology and plastic surgery. The HandPICO handpiece is indicated for: 532nm (pico-second): Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange; Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. 1064nm (pico-second): Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple; Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm (nano-second): Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV; Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III. 1064nm (nano-second): Treatment of benign pigmented lesions on Fitzpatrick skin types I-VI; Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI. Prescription Use (Part 21 CFR 801 Subpart D).

Device Story

HandPICO is a laser handpiece accessory for the Vydence Laser Family; emits laser energy in 532nm and 1064nm wavelengths; operates in both pico-second and nano-second pulse durations. Used by physicians in clinical settings for tattoo removal and treatment of benign pigmented lesions. Device delivers targeted laser energy to skin tissue; energy absorption by tattoo ink or melanin leads to fragmentation of target particles; cleared by immune system. Physician selects wavelength and pulse mode based on skin type and target lesion/ink color. Output affects clinical decision-making by providing non-invasive option for dermatological conditions; benefits patients through removal of unwanted tattoos and pigmented lesions.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and comparison of technological characteristics to the existing Vydence Laser Family platform.

Technological Characteristics

Laser surgical instrument; emits 532nm and 1064nm wavelengths; dual-mode operation (pico-second and nano-second pulses); handpiece form factor; connects to Vydence Laser Family console; Class II device (21 CFR 878.4810).

Indications for Use

Indicated for patients requiring tattoo removal or treatment of benign pigmented lesions. HandPICO 532nm (pico/nano) for Fitzpatrick I-III (tattoos) or I-IV (pigmented lesions). HandPICO 1064nm (pico/nano) for Fitzpatrick I-VI (tattoos) or I-IV/VI (pigmented lesions).

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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May 5, 2022

Vydence Medical Industria E Comercio Ltda % Kathv Mavnor Regulatory consultant Kathy Maynor 26 Rebecca Ct Homosassa, Florida 34446

Re: K220041

Trade/Device Name: HandPICO 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: December 10, 2021 Received: January 5, 2022

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.

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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

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# Indications for Use

510(k) Number (if known) K220041

#### Device Name

Vydence Laser Family (Addition of HandPICO Handpiece)

Indications for Use (Describe)

IPL 390nm-510nm Filter

· The treatment of inflammatory acne (acne vulgaris);

· The treatment of leukoderma, including vitiligo (acquired leukoderma).

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 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 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 and spider angiomas, poikiloderma of Civatte, 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 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.

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· 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 esions 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 Civatte, leg veins and venous malformations;

· removal of unwanted hair, for stable long term or permanent hair reduction (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 (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 types, 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)

· 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 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;

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# 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., dermatophytes Trichophyton 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 (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;

· 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 Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

### 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

· fractional laser handpiece is intended for use in skin resurfacing

· collimated laser handpiece is intended for the treatment of fine lines and wrinkles; treatment of atrophic acne scars;

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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; epidermal lesions (benign pigmented lesions) such as solar melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia, erythematous rosacea, angiomas, poikiloderma of Civatte and superficial venous malformations.

1064nm Fiber Delivered Handpiece (Zye and One)

In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lesions 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-VI), 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.).

· In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;

# HandPICO Handpiece

532nm (pico-second):

- Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange;
- · Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
- 1064nm (pico-second):

· Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm (nano-second):

- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
- · Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III 1064nm (nano-second):
- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-VI
- Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI

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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)

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