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Powered Laser Surgical Instrument-Trixel II CO2 Laser

FDA UDI

Class II (US FDA UDI)

by Beijing Syntech Laser Co., Ltd.

Identity

Trade Name
Powered Laser Surgical Instrument-Trixel II CO2 Laser FDA UDI
Generic Name
General/multiple surgical solid-state/carbon dioxide laser system FDA UDI
Model / Reference
UFL-60 FDA UDI

Identifiers

Primary DI / UDI-DI
06970285179057 FDA UDI
510(k) Number
K110434 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical solid-state/carbon dioxide 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

No

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

Powered Laser Surgical Instrument-Trixel II CO2 Laser by Beijing Syntech Laser Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K110434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beijing Syntech Laser Co., Ltd.

Sources (1)

  • FDA UDI c049ddd5-108d-4b9a-b3d3-6052b39f03e5 34 fields · synced May 30, 2026