Glace

Basic Information

• Brand Name: Glace
• Primary DI: 00817495025414
• Version / Model: FIN102938
• Company Name: Candela Corporation
• Labeler DUNS: 053468385
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-07
• Public Version: 1
• Public Version Date: 2025-10-15
• Public Version Status: New
• Public Device Record Key: a7e8d1d9-f60e-4be6-a072-ece3cdd5319f

Device Description

Glace VACUUM CUPPING HANDPIECE VACUUM CUPPING CAP

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47983	Pressure-wave skin contouring system applicator, pneumatic	A hand-held device designed to apply to the skin surface pneumatically-generated radial pressure waves, at selected impulse frequencies, intended to reduce the appearance of cellulite and possibly treat other skin/muscle conditions. It connects to an electrical control unit distally, and proximally has a head portion that is applied to the surface of the treatment area. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817495025414	GS1