SANDRO Dual

Wontech Co., Ltd.

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

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252877
Device name
SANDRO Dual
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-09-10
Decision date
2025-12-19
Submission type
Traditional
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The SANDRO Dual Laser 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 vascular lesions (such as pant-wine stains, hemangiomas, telangiectasias) 1064nm Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus 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), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. 1064nm 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 SANDRO Dual Laser 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 vascular lesions (such as pant-wine stains, hemangiomas, telangiectasias) 1064nm Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus 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), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. 1064nm 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 SANDRO Dual laser system consists of laser resonator, touch screen monitor, optical fiber with handpiece, and foot switch. 1) Nd:YAG Laser A certain amount of electric power set by the LCD monitor is permitted to the laser resonator through the power supply. Then, the laser resonator delivers the electrical energy to the flash lamp which converts the electrical energy into the light source. This concentrated light source is radiated on the medium of Nd:YAG, resulting in the laser energy source. The laser energy generated by the medium of Nd:YAG is converted to the heat energy once it gets to human skin surface and used for a variety of medical purpose such as an ablation, incision and removal of targeted tissue. 2) Alexandrite Laser A certain amount of electric power set by the LCD monitor is permitted to the laser resonator through the power supply. Then, the laser resonator delivers the electrical energy to the flash lamp which converts the electrical energy into the light source. This concentrated light source is radiated on the medium of Alexandrite, resulting in the ultimate laser energy source. The laser energy generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for a variety of medical purpose such as an ablation, incision and removal of targeted tissue.

Summary parsed at:2026-06-01 05:24:24 UTC

Predicate devices

3

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0

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