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Waterlase Laser System Gold Handpiece

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name
Waterlase Laser System Gold Handpiece FDA UDI
Generic Name
Dental solid-state laser system FDA UDI
Device Name
A reusable handpiece intended for use with Waterlase laser systems in a variety of dental hard-tissue and soft-tissue procedures. FDA UDI
Model / Reference
6200500 Refurbished FDA UDI
Description
A reusable handpiece intended for use with Waterlase laser systems in a variety of dental hard-tissue and soft-tissue procedures. FDA UDI

Identifiers

Primary DI / UDI-DI
00647529002483 FDA UDI
510(k) Number
K101658 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dental solid-state laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Waterlase Laser System Gold Handpiece by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K101658 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biolase, Inc.

Sources (1)

  • FDA UDI f72cf2eb-1f6b-4495-aff1-c73522765c8f 36 fields · synced May 31, 2026