FSE ALEX2 532 HP ASSY

Basic Information

• Brand Name: FSE ALEX2 532 HP ASSY
• Primary DI: 00817495022765
• Version / Model: 7122-57-9150
• Company Name: Candela Corporation
• Labeler DUNS: 053468385
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-25
• Public Version: 4
• Public Version Date: 2022-10-12
• Public Version Status: Update
• Public Device Record Key: 33c936e8-442d-4812-9e78-0b184c97cdcc

Device Description

Handpiece Assembly

Device Characteristics

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

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
45221	Dermatological laser beam guiding handpiece	A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817495022765	GS1
Previous	08174950202769	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K081324	000