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Lucas Plus

Amt Engineering Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Amt Engineering Co., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

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Cited in this 510(k)

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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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