Manufacturer
Classys, Inc.CuRAS hybrid
Country / Region:Korea, Republic of (KR)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
- K253123
- Device name
- CuRAS hybrid
- Company
- Classys, Inc.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-25
- Decision date
- 2025-11-20
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingPigment treatmentVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The CuRAS hybrid Nd:YAG laser system is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength: - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: - Tattoo removal (light ink: red, sky blue, green) - Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi - Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis - Skin Resurfacing for Acne Scars and Wrinkles
Intended Use
The CuRAS hybrid Nd;YAG laser system is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength: - Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus. 1064nm Wavelength: - Tattoo removal: dark ink (black, blue and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles.
Device Description
The CuRAS hybrid is a laser system indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis, at wavelengths of 532 nm and 1064 nm. In addition, optional dye handpieces provide output at wavelengths of 585 nm and 650 nm. The CuRAS hybrid system consists of a main unit, power cable, an articulated arm that transmits the laser energy, interchangeable handpieces, a footswitch, key switch, remote interlock connector, and operator/patient protective eyewear. The laser output is user-controlled via the footswitch.
Summary parsed at:2026-06-01 05:24:34 UTC
Predicate devices
3—
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Not ingested
CuRAS Nd:YAG Laser
MIIN
K253123 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253123 as a predicate
