Identity
- Trade Name
- CO2RE System, Packaged (Japan) FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- CO2RE System, Packaged (Japan) FDA UDI
- Model / Reference
- FG70412JP FDA UDI
- Description
- CO2RE System, Packaged (Japan) FDA UDI
Identifiers
- Catalog Number
- FG70412JP FDA UDI
- Primary DI / UDI-DI
- 00817495024271 FDA UDI
- 510(k) Number
- K181523 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological carbon dioxide laser system
CO2RE System, Packaged (Japan) by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181523 also covers:
- 5-Pk, Internal hygienic, CO2RE Intima — Candela Corporation
- 5-Pk, external hygienic, CO2RE Intima — Candela Corporation
- CO2RE Intima — Candela Corporation
- CO2RE Intima — Candela Corporation
- CO2RE System for US, Packaged — Candela Corporation
- CO2RE system — Candela Corporation
- Handpiece, external CO2RE Intima — Candela Corporation
- Intima hygienic Accessories Kit, CO2RE — Candela Corporation
- Purple Swivel Lens CO2RE — Candela Corporation
- Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation
- Regular Internal Handpiece Sterile Single-Use, CO2RE Intima — Candela Corporation
- Standard 2 Hand-piece packing Assy, CO2RE — Candela Corporation
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 II | Pending data |
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Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI 54251e12-f3b9-4cbc-8b15-d6680ba1e420 36 fields · synced Jun 8, 2026