Manufacturer
Beijing HuaCheng Taike Technology Co., Ltd.Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
Beijing HuaCheng Taike Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253828
- Device name
- Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-12-01
- Decision date
- 2026-02-27
- Submission type
- Traditional
- Technology type
- Alexandrite(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Medical Alexandrite and Nd:YAG laser Therapy System is indicated for the following at the specified wavelength: 755nm - Temporary hair reduction. - Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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 photocoagulation of dermatological benign vascular lesions (such as portwine stains, hemangiomas, telangiectasias). 1064nm - 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 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. - Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. - Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Intended Use
The Medical Alexandrite and Nd:YAG laser Therapy System is indicated for the following at the specified wavelength: 755nm Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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 photocoagulation of dermatological benign vascular lesions (such as portwine stains, hemangiomas, telangiectasias) 1064nm 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 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. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Device Description
The Medical Alexandrite and Nd:YAG laser Therapy System is a Nd: YAG and Alexandrite laser operating at wavelengths of 1064 nm and 755 nm. The Medical Alexandrite and Nd:YAG laser Therapy System consists of the main unit, optical fiber, handpiece, treatment tip, footswitch, and handpiece holder and other accessories. The laser output is delivered to the skin through the optical fiber terminated by the handpiece. The Medical Alexandrite and Nd:YAG laser Therapy System is used for a variety of medical purpose. For treatment, the user can select the appropriate wavelength and the related output energy value by pressing UP and/or DOWN button from the LCD display/Touch Pad located on the front of the main unit.
Summary parsed at:2026-06-01 05:18:54 UTC
Predicate devices
1SANDRO Dual
K253828 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
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