Identity
- Trade Name
- EdgePro FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno). FDA UDI
- Model / Reference
- Tip Assembly - Two-21mm, WL JUNO FDA UDI
- Description
- A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno). FDA UDI
Identifiers
- Catalog Number
- 6200184 FDA UDI
- Primary DI / UDI-DI
- 00647529004074 FDA UDI
- 510(k) Number
- K213428 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable 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
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 — 21 Millimeter FDA UDIOuter Diameter — 320 Micrometer FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
EdgePro by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, reusable.
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- Twister — WISDOM MEDICAL TECHNOLOGY, LLC · Class II
Cleared under the same submission
K213428 also covers:
- EdgePro — Biolase, Inc.
- EdgePro — Biolase, Inc.
- EdgePro — Biolase, Inc.
- EdgePro — Biolase, Inc.
- EdgePro — Biolase, Inc.
- EdgePro — Biolase, Inc.
- EdgePro — Biolase, Inc.
- EdgePRO™ — US Endodontics, LLC
- EdgePRO™ — US Endodontics, LLC
- EdgePRO™ — US Endodontics, LLC
- EdgePRO™ — US Endodontics, LLC
- EdgePRO™ — US Endodontics, LLC
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 83e397dc-ebc9-485b-89f7-14b82a557c69 37 fields · synced Jun 1, 2026