Identity
- Trade Name
- Zaffiro IR Treatment Applicator FDA UDI
- Generic Name
- Dermabrasion brush, rotary FDA UDI
- Device Name
- Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System FDA UDI
- Model / Reference
- ZIR FDA UDI
- Description
- Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System FDA UDI
Identifiers
- Catalog Number
- 300-1104 FDA UDI
- Primary DI / UDI-DI
- 00850017374065 FDA UDI
- FDA Product Code
- GFE FDA UDI
- GMDN Term
- Dermabrasion brush, rotary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermabrasion brush, rotary
Zaffiro IR Treatment Applicator by Neauvia North America, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermabrasion brush, rotary.
- CONAIR — CONAIR LLC. · Class I
- Standard Handpiece Tubing — Zeltiq Aesthetics, Inc. · Class I
- CONAIR — CONAIR LLC. · Class I
- CONAIR — CONAIR LLC. · Class I
- SPP Device, Dermalinfusion — Zeltiq Aesthetics, Inc. · Class I
- CONAIR — CONAIR LLC. · Class I
- Silver Peel — Silhouet-Tone Corporation · Class I
- CONAIR — CONAIR LLC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neauvia North America, Inc
Sources (1)
- FDA UDI 0ae2ba00-ca62-45f7-8781-4f1abcecaf3e 35 fields · synced May 30, 2026