FDA.reportPublic FDA data

Glace

Primary DI
00817495025438
Brand
Glace
Company
Candela Corporation
Model
FIN102954
Device description
Glace Hydro dermabrasion HP BOX 20 UNITS ABRASIVE DIAMOND TIP FINE GRIT
Published
2025-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817495025438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817495025438008174950254388174950254380817495025438

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion burA 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.

Regulatory Flags#

DUNS number
053468385
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817495025070Refurbished Applicator 1550 FIN1012082025-05-20
00817495025087Refurbished Applicator 1940FIN1012072025-05-20
00817495024622Glace SBA1038402025-10-07
00817495025292Glace SBA1038782025-10-07
00817495025308Glace SBA1038892025-10-07
00817495025315Glace SBA1039002025-10-07
00817495025339Glace FIN1029552025-10-07
00817495025346Glace FIN1029562025-10-07
00817495025353Glace FIN1029572025-10-07
00817495025360Glace FIN1044922025-10-07
00817495025377Glace FIN1047562025-10-07
00817495025384Glace FIN1045952025-10-07
00817495025391Glace FIN1045942025-10-07
00817495025407Glace MCN1037982025-10-07
00817495025414Glace FIN1029382025-10-07
00817495025421Glace FIN1029422025-10-07
008174950244005-Pk, external hygienic, CO2RE IntimaKT76685KT766852023-10-20
00817495024424Handpiece, external CO2RE IntimaAS90245AS902452023-10-20
00817495024431Purple Swivel Lens CO2REAS90411AS904112023-10-20
00817495024578SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIIKT75672KT756722023-10-20

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Primary DI, Brand, Company table
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00817495025315Glace Candela CorporationGFE2025-10-07
00817495025339Glace Candela CorporationGFE2025-10-07
00817495025346Glace Candela CorporationGFE2025-10-07
00817495025353Glace Candela CorporationGFE2025-10-07
00817495025360Glace Candela CorporationGFE2025-10-07
00817495025377Glace Candela CorporationGFE2025-10-07
00817495025384Glace Candela CorporationGFE2025-10-07
00817495025391Glace Candela CorporationGFE2025-10-07
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