Identity
- Trade Name
- Epic T-Series Diode Laser System FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries. FDA UDI
- Model / Reference
- 7400055 FDA UDI
- Description
- A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries. FDA UDI
Identifiers
- Catalog Number
- 7400055 FDA UDI
- Primary DI / UDI-DI
- 00647529000267 FDA UDI
- 510(k) Number
- K121286 FDA UDI
- FDA Product Code
- GEX FDA UDIILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5500 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
Category: Musculoskeletal/physical therapy laser, professional
Epic T-Series Diode Laser System by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Musculoskeletal/physical therapy laser, professional.
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- EVRL — Erchonia Corporation · Class II
- Regenalase — IPG Medical Corporation · Class II
- Phoenix Thera-Lase system — Phoenix Thera-Lase Systems, LLC · Class II
- MedX Rehab Portable Laser — MedX Health Corp · Class II
- Dimed — Wuhan Dimed Laser Technology Co., Ltd. · Class II
Cleared under the same submission
K121286 also covers:
- Diode Laser System Deep Tissue Handpiece — Biolase, Inc.
- Diode Laser System Whitening Handpiece — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
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
- Biolase, Inc.
Sources (1)
- FDA UDI 29453d22-c206-4516-b21c-34c3538ec5e4 36 fields · synced May 30, 2026