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reepot Nd; YAG laser system

Ilooda Co,., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Ilooda Co,., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

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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

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