Identity
- Trade Name
- LiteTouch FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety of procedures in oral and maxillofacial surgery and dentistry. This product is a kit that contains consul,applicator and an accessory kit. FDA UDI
- Model / Reference
- LI-FG0012A FDA UDI
- Description
- The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety of procedures in oral and maxillofacial surgery and dentistry. This product is a kit that contains consul,applicator and an accessory kit. FDA UDI
Identifiers
- Catalog Number
- LI-FG0012A FDA UDI
- Primary DI / UDI-DI
- 07290016784015 FDA UDI
- 510(k) Number
- K061966 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Dental solid-state laser system
LiteTouch 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
K061966 also covers:
- E1 Handpiece, LT — Light Instruments
- LiteTouch Applicator — Light Instruments
- Straight Handpiece, LT — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
- TIP for LITETOUCH — Light Instruments
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 036f0678-0a87-46cf-a57a-9687a678e1d0 36 fields · synced Jun 6, 2026