Manufacturer
Ids, LimitedSMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K222485
- Device name
- SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
- Company
- Ids, Limited
- 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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