Identity
- Trade Name
- Handpiece, external CO2RE Intima FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- Handpiece, external CO2RE Intima FDA UDI
- Model / Reference
- AS90245 FDA UDI
- Description
- Handpiece, external CO2RE Intima FDA UDI
Identifiers
- Catalog Number
- AS90245 FDA UDI
- Primary DI / UDI-DI
- 00817495024424 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological carbon dioxide laser system
Handpiece, external CO2RE Intima by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological carbon dioxide laser system.
- MedArt Intenz — Medart A/S · Class II
- DEKA SMART US-20D — EL.EN. SPA · Class II
- DEKA SMARTXIDE TOUCH — EL.EN. SPA · Class II
- Fraxis Duo ARM — ILOODA.CO., LTD · Class II
- Edge Arm — Jeisys Medical Inc. · Class II
- Secret PRO Scanner Handpiece — CLASSYS Inc. · Class II
- DEKA SMARTXIDE 50 — EL.EN. SPA · Class II
- ATL — Advanced Technology Laser Co., Ltd. · Class II
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, Packaged (Japan) — Candela Corporation
- CO2RE system — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI 640f31bf-5482-4687-9c8b-e8820b56a2f4 36 fields · synced Jun 8, 2026