Glace

Basic Information

• Brand Name: Glace
• Primary DI: 00817495025308
• Version / Model: SBA103889
• 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: a6675c07-dcc1-449d-b443-8f3ab97a5852

Device Description

Glace Hydro dermabrasion HP ABRASIVE DIAMOND TIP COARSE GRIT

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
65745	Dermabrasion bur	A rotary abrasive endpiece intended to be fitted to a powered motorized handpiece (not included) operated by a healthcare professional to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) for the removal of scars, tattoos, pigmented nevi, fine wrinkles, and/or other irregularities. It consists of a rough head of various shapes made of hard materials (e.g., diamond, metal carbide); it does not include bristles (i.e., not a brush). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817495025308	GS1