Identity
- Trade Name
- Diode Laser Tips FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use, non-sterile FDA UDI
- Device Name
- A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems. FDA UDI
- Model / Reference
- E4-250 EZ Tips FDA UDI
- Description
- A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems. FDA UDI
Identifiers
- Catalog Number
- 7400058 FDA UDI
- Primary DI / UDI-DI
- 00647529000427 FDA UDI
- 510(k) Number
- K130465 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use, non-sterile 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 250 Millimeter FDA UDIOuter Diameter — 400 Micrometer FDA UDI
Category: General/multiple surgical laser system beam guide, single-use, non-sterile
Diode Laser Tips by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical laser system beam guide, single-use, non-sterile.
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
- Diode Laser Tips — Biolase, Inc. · Class II
Cleared under the same submission
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 3aac34a9-008b-445e-b184-694cbcb896a0 37 fields · synced Jun 6, 2026