SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

Ids, Limited

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K222485
Device name
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-08-17
Decision date
2023-03-29
Submission type
Traditional
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The SMARTRION COMBI Laser System is indicated for the following:

- 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).
- 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 (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- The laser is 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.
- 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.

Intended Use

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).

Summary parsed at:2026-06-01 05:31:56 UTC

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