Identity
- Trade Name
- 8-18/hr® - Fiber handpiece EUDAMED8-18/hr FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- 8-18/hr® - Fiber handpiece EUDAMED8-18/hr fiber delivered laser handpiece FDA UDI
- Model / Reference
- 21805 EUDAMEDFDA UDI
- Description
- 8-18/hr fiber delivered laser handpiece FDA UDI
Identifiers
- Catalog Number
- 21805 FDA UDI
- Primary DI / UDI-DI
- 07898961835259 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07898961835259 EUDAMED
- 510(k) Number
- K190007 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dermatological laser beam guiding handpiece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 laser beam guiding handpiece
8-18/hr by Vydence Medical — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dermatological laser beam guiding handpiece.
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Cleared under the same submission
K190007 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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
- Vydence Medical
Sources (2)
- FDA UDI e21211aa-a60b-49ad-bf8a-31c3c2a829f8 37 fields · synced Jul 12, 2026
- EUDAMED 97b50104-291a-4351-a5fa-315dcede0cef 61 fields · synced Jul 12, 2026