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510(k) Data Aggregation
K Number
K123777Device Name
MULTILASER SYSTEM
Manufacturer
ULTRALIGHT LASER TECHNOLOGIES, LLC
Date Cleared
2013-04-11
(122 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ULTRALIGHT LASER TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:
- Hair Removal
- Permanent hair reduction
- Treatment of vascular lesions
- Treatment of benign pigmented lesions
- Treatment of Leg Veins
- Treatment for pseudofolliculitis barbae
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
- Hair Removal (650nm filter)
- Permanent hair reduction (650nm filter)
- Treatment of vascular lesions (510nm filter)
- Treatment of benign pigmented lesions (510 nm filter)
- Mild to Moderate inflammatory acne (450nm filter)
Device Description
The MultiLaser System consists of a console that houses the power supply, control electronics and user interface and four separate handpiece. The four handpieces consist of an Er:YAG laser handpiece, an Nd:YAG laser handpiece, a Diode laser handpiece and an IPL handpiece.
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