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510(k) Data Aggregation
K Number
K241672Device Name
COPRO 3
Manufacturer
Date Cleared
2024-09-06
(87 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMT Engineering Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing.
Device Description
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K Number
K230340Device Name
Lucas Plus
Manufacturer
Date Cleared
2023-05-04
(86 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMT Engineering Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Device Description
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