Identity
- Trade Name
- DMV Luma Serter Plus FDA UDI
- Generic Name
- Rigid contact lens inserter/remover FDA UDI
- Device Name
- 45 degree Inserter for large contact lenses to be used with a pen light. No suction FDA UDI
- Model / Reference
- 424 FDA UDI
- Description
- 45 degree Inserter for large contact lenses to be used with a pen light. No suction FDA UDI
Identifiers
- Catalog Number
- 424 FDA UDI
- Primary DI / UDI-DI
- 00080875974248 FDA UDI
- 510(k) Number
- K830496 FDA UDI
- FDA Product Code
- KYE FDA UDI
- GMDN Term
- Rigid contact lens inserter/remover FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5420 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid contact lens inserter/remover
DMV Luma Serter Plus by DMV Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid contact lens inserter/remover.
- Zenlens Patient Kit — Bausch & Lomb Incorporated · Class II
- DMV Vented Scleral Cup — DMV Corporation · Class I
- DMV 45 — DMV Corporation · Class I
- DMV MiniCup — DMV Corporation · Class I
- DMV Luma Serter — DMV Corporation · Class I
- DMV Ultra — DMV Corporation · Class I
- DMV Classic — DMV Corporation · Class I
- DMV Scleral Cup — DMV Corporation · Class I
Cleared under the same submission
K830496 also covers:
- DMV 45 — DMV Corporation
- DMV Classic — DMV Corporation
- DMV Luma Serter — DMV Corporation
- DMV Magic Touch — DMV Corporation
- DMV MiniCup — DMV Corporation
- DMV Scleral Cup — DMV Corporation
- DMV Soft Lens Handler — DMV Corporation
- DMV Traditional — DMV Corporation
- DMV Ultra — DMV Corporation
- DMV Vented Scleral Cup — DMV 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 I | Pending data |
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Manufacturer
- Manufacturer
- DMV Corporation
Sources (1)
- FDA UDI abd4a30c-0347-4654-917b-d0c3377cae94 35 fields · synced May 30, 2026