SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

K222485 · Ids, Limited · GEX · Mar 29, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K222485
• Device Name: SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
• Applicant: Ids, Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMARTRION COMBI Laser System is indicated for the following: 755nm The SMARTRION COMBI Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting for melanin in hair follicles. Permanent hair reduction 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. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photo-coagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm The SMARTRION COMBI Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. 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. Coagulation and hemostasis of soft tissue. 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 (sigmificant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is 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. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Device Story

SMARTRION COMBI is a dual-wavelength laser system (755nm Alexandrite and 1064nm Long Pulsed Nd:YAG). Device delivers laser energy to target melanin in hair follicles, vascular structures, or pigmented lesions via selective photothermolysis. Operated by clinicians in dermatology or plastic surgery settings. Output consists of controlled laser pulses for hair reduction, lesion treatment, or soft tissue coagulation. Clinical benefit includes permanent hair reduction, lesion clearance, and improved skin appearance. System provides non-invasive treatment options for various dermatological conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Dual-wavelength laser system (755nm Alexandrite and 1064nm Nd:YAG). Class II device (21 CFR 878.4810). Intended for dermatological applications including hair reduction, vascular lesion treatment, and soft tissue coagulation.

Indications for Use

Indicated for hair reduction, treatment of benign pigmented lesions, wrinkles, and vascular lesions (e.g., port-wine stains, telangiectasias) in patients of all skin types (Fitzpatrick I-VI), including tanned skin. 1064nm wavelength also indicated for soft tissue coagulation/hemostasis, tattoo reduction, and scar pigmentation reduction.

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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 29, 2023

IDS, Limited % Alexander Henderson Official Correspondent BraunSolutions Regulatory Group 2298 Americus Blvd. East Unit 14 Clearwater, Florida 33763

Re: K222485

Trade/Device Name: SMARTRION COMBI/Alexandrite & Long Pulsed Nd: YAG Laser 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: January 12, 2023 Received: January 20, 2023

Dear Alexander Henderson:

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

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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,

Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is black and stands out against a white background. The name appears to be a person's name, with the "-S" possibly indicating an initial or a designation.

Jianting Wang Acting 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) K222485

## Device Name

SMARTRION COMBI / Alexandrite & Long Pulsed Nd:YAG Laser

Indications for Use (Describe)

The SMARTRION COMBI Laser System is indicated for the following:

755nm

The SMARTRION COMBI Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting for melanin in hair follicles. Permanent hair reduction 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. On all skin types (Fitzpatrick I-VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles. The photo-coagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm

The SMARTRION COMBI Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. 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. Coagulation and hemostasis of soft tissue.

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 (sigmificant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is 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.

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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