Manufacturer
Ilooda Co,., Ltd.CuRAS 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
Device details
FDA 510(k) registration fields
- K number
- K173038
- Device name
- CuRAS Nd:YAG Laser
- Company
- Ilooda Co,., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-09-28
- Decision date
- 2017-12-01
- 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 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
Intended Use
The CuRAS 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 Nd;YAG laser system is comprised of the following major components: 1. The main console unit 2. Delivery handpieces 3. Footswitch 4. Accessories. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
Summary parsed at:2026-06-01 06:01:10 UTC
Predicate devices
1—
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Not ingested
K173038 references 1 predicate/reference device
Cited as predicate
4Nd: YAG Laser Therapy Systems
reepot Nd; YAG laser system
Q-Switched Nd: YAG Laser machine (LFS-C13U)
CuRAS hybrid
4 submissions cite K173038 as a predicate
