Identity
- Trade Name
- Waterlase Laser Tips FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems. FDA UDI
- Model / Reference
- MC12-9 FDA UDI
- Description
- A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00647529000830 FDA UDI
- 510(k) Number
- K101658 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
- Outer Diameter — 1200 Micrometer FDA UDILength — 9 Millimeter FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
Waterlase 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, reusable.
- ProFlex — INNOVAQUARTZ LLC · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- Flex-G Laser Fiber with Extended Length Sheath — OPTICAL INTEGRITY, INC. · Class II
- ProFlex — INNOVAQUARTZ LLC · Class II
- Q-Lase™ Side-Firing Laser Fiber with SMA Connector — OPTICAL INTEGRITY, INC. · Class II
- Laser Applicator Non-cooled Instructions for Use — Clinical Laserthermia Systems AB · Class II
- Twister — WISDOM MEDICAL TECHNOLOGY, LLC · Class II
Cleared under the same submission
K101658 also covers:
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase 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 5b1b5d66-f5f5-4f57-b6a3-7cd8705ae147 36 fields · synced May 30, 2026