Identity
- Trade Name
- D-STORM FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- Base (station) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Base (station) FDA UDI
Identifiers
- Catalog Number
- LI-FGD002(X) FDA UDI
- Primary DI / UDI-DI
- 07290016784046 FDA UDI
- 510(k) Number
- K093048 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental solid-state 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Dental solid-state laser system
D-Storm by Light Instruments — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental solid-state laser system.
- Waterlase iPlus Dental Laser System — Biolase, Inc. · Class II
- Waterlase Laser Tips — Biolase, Inc. · Class II
- Waterlase Laser Tips — Biolase, Inc. · Class II
- Waterlase Laser Tips — Biolase, Inc. · Class II
- InPulse Dental Laser — Beyond International Inc. · Class II
- Waterlase Laser Tips — Biolase, Inc. · Class II
- Waterlase Laser Tips — Biolase, Inc. · Class II
- Waterlase Laser Tips — Biolase, Inc. · Class II
Cleared under the same submission
K093048 also covers:
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
- Light Instruments
Sources (1)
- FDA UDI cff2f1a7-77e4-4231-bbe6-fbf5459c31d9 35 fields · synced May 30, 2026