Identity
- Trade Name
- V-Nd:YAG HP Basic FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- V-Nd:YAG HP Basic FDA UDI
- Model / Reference
- VTL44030 FDA UDI
- Description
- V-Nd:YAG HP Basic FDA UDI
Identifiers
- Catalog Number
- VTL44030 FDA UDI
- Primary DI / UDI-DI
- 07290016746174 FDA UDI
- 510(k) Number
- K133837 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam guiding handpiece 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 laser beam guiding handpiece
V-Nd:YAG HP Basic by Viora Ltd — Class II — FDA UDI — listed in FDA GUDID — 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
K133837 also covers:
- V- IPL Handpiece — VIORA LTD
- V-IPL Filter AC-415 — VIORA LTD
- V-IPL Filter HR-570 — VIORA LTD
- V-IPL Filter HR-630 — VIORA LTD
- V-IPL Filter HR-755 — VIORA LTD
- V-IPL Filter SR-580 — VIORA LTD
- V-IPL Filter VP-530 — VIORA LTD
- V-IPL HP Basic — VIORA LTD
- V-IPL HP Extended — VIORA LTD
- V-IPL HP Full — VIORA LTD
- V-IPL Optic set Basic — VIORA LTD
- V-IPL Optic set Extended — VIORA LTD
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
- Viora Ltd
Sources (1)
- FDA UDI 58f75167-aecd-4a39-8315-06d70d021782 36 fields · synced Jun 8, 2026