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Epic Pro Diode Laser System
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K163128
Identity
- Trade Name
- Epic Pro Diode Laser System FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
- Model / Reference
- Dental soft tissue diode laser system refurbished FDA UDI
- Description
- A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Identifiers
- Catalog Number
- 7410004P FDA UDI
- Primary DI / UDI-DI
- 00647529003558 FDA UDI
- 510(k) Number
- K172771 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
Epic Pro Diode Laser System by Biolase, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Dental diode laser system.
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- 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
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163128 | Class II | Active |
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Manufacturer
- Manufacturer
- Biolase, Inc.
Sources (2)
- FDA UDI a2bed2f4-b02e-4d75-8eba-bdddeb61e93a 60 fields · synced Jun 18, 2026
- FDA 510(k) K163128 1 fields · synced Jun 4, 2026