Identity
- Trade Name
- iLase Handpiece FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of dental soft-tissue procedures such as incision, excision, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, as well as laser periodontal procedures. The laser has a wavelength of 940nm. The laser energy is delivered to the treatment site via a single-use laser tip attached to the handpiece. The handpiece is reusable with a removable cover which requires sterilization prior to each patient use. The iLase packaging contains one handpiece and accessories such as laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips. The product is also available as a system packaged with a charging station which is used for charging and storing the iLase and replacement batteries. FDA UDI
- Model / Reference
- iLase FDA UDI
- Description
- iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of dental soft-tissue procedures such as incision, excision, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, as well as laser periodontal procedures. The laser has a wavelength of 940nm. The laser energy is delivered to the treatment site via a single-use laser tip attached to the handpiece. The handpiece is reusable with a removable cover which requires sterilization prior to each patient use. The iLase packaging contains one handpiece and accessories such as laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips. The product is also available as a system packaged with a charging station which is used for charging and storing the iLase and replacement batteries. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00647529002292 FDA UDI
- 510(k) Number
- K093852 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental diode 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental diode laser system
iLase Handpiece by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Biolase, Inc.
Sources (1)
- FDA UDI 9675cf05-1923-437f-80c8-901c84e4f274 35 fields · synced Jun 8, 2026