Manufacturer
Amt Engineering Co., Ltd.Lucas Plus
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K230340
- Device name
- Lucas Plus
- Company
- Amt Engineering Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-02-07
- Decision date
- 2023-05-04
- 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
Lucas Plus 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) - Removal of epidermal pigmented lesions, minor vascular lesions, telangiectasias - Treatment of lentigines, cafe-au-lait, seborrheic keratoses, Becker's nevi, freckles - Treatment of post inflammatory hyperpigmentation (PIH) 1064nm Wavelength: - Tattoo removal: dark ink (black, blue, green) - Removal of nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of common nevi, melasma - Skin resurfacing procedures for the treatment of acne scars, wrinkles
Intended Use
Lucas Plus 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,) Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles, Treatment of Post Inflammatory Hyperpigmentation (PIH) 1064nm Wavelength: Tattoo removal: dark ink (black, blue, green ) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle
Summary parsed at:2026-06-01 05:32:34 UTC
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