Manufacturer
Ilooda Co,., Ltd.reepot Nd; YAG laser system
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
- K222555
- Device name
- reepot Nd; YAG laser system
- 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
- 2022-08-23
- Decision date
- 2022-09-23
- 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 Reepot 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
Intended Use
The Reepot 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.
Device Description
The reepot Nd;YAG laser system is comprised of the following major components: 1) Laser system console 2) LCD control panel 3) VSLS handpieces (included camera and LCD display) 4) Footswitch. 5) 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 05:40:22 UTC
Predicate devices
1CuRAS Nd:YAG Laser
K222555 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K222555 as a predicate