Applicator Frax 1550 1550 nm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Frax 1550 EUDAMEDApplicator Frax 1550 1550 nm FDA UDI
- Generic Name
- Multi-modality skin surface treatment system generator FDA UDI
- Device Name
- Frax 1550 EUDAMED
- Model / Reference
- 9APP7829-CNDL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495023410 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817495023410 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Multi-modality skin surface treatment system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multi-modality skin surface treatment system generator
Applicator Frax 1550 1550 nm by Candela Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Candela Corporation
Sources (2)
- FDA UDI 0a0b3318-b44a-48dd-9608-b69ca0d354a9 32 fields · synced Jun 19, 2026
- EUDAMED 80657577-0591-4d0d-9318-941de8724369 61 fields · synced Jun 19, 2026