Identity
- Trade Name
- Epic Hygiene Diode Laser System FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedures. The dental diode laser system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
- Model / Reference
- Handpiece, 1pk FDA UDI
- Description
- A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedures. The dental diode laser system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Identifiers
- Catalog Number
- 7420006 FDA UDI
- Primary DI / UDI-DI
- 00647529004159 FDA UDI
- 510(k) Number
- K192430 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental diode laser system
Epic Hygiene Diode Laser System by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental diode laser system.
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- Dental Diode Laser System — Lazon Medical Laser Co., Ltd. · Class II
- STERLING® — Den-Mat Holdings, LLC · Class II
- SOL® — Den-Mat Holdings, LLC · Class II
- BLU — Peter Brasseler Holdings, LLC · Class II
- Pioneer Elite Perio Tip — CAO GROUP, INC. · Class II
- SL3® — Den-Mat Holdings, LLC · Class II
Cleared under the same submission
K192430 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 |
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Manufacturer
- Manufacturer
- Biolase, Inc.
Sources (1)
- FDA UDI e4f3a277-1c16-4927-a0b8-affe4014781b 36 fields · synced May 30, 2026