ATL

Basic Information

• Brand Name: ATL
• Primary DI: 06970507240015
• Version / Model: Angelite-SDC
• Company Name: Advanced Technology Laser Co.,Ltd.
• Labeler DUNS: 547070719
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-20
• Public Version: 4
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: 48b6bad7-c8ab-4a1a-af75-e5783953dfc2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58935	Intense pulsed light skin surface treatment system	A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970507240015	GS1

Premarket Submissions

Submission Number	Supplement Number
K083915	000