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Accu-Beam

FDA UDI

Class II (US FDA UDI)

by Transamerican Technologies International

Identity

Trade Name
Accu-Beam FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
Lumenis re-usable fiberoptic handpiece for lasers. Straight/Rigid - 35cm, 11ga, ID 2.6mm. FDA UDI
Model / Reference
9171 FDA UDI
Description
Lumenis re-usable fiberoptic handpiece for lasers. Straight/Rigid - 35cm, 11ga, ID 2.6mm. FDA UDI

Identifiers

Catalog Number
9171L FDA UDI
Primary DI / UDI-DI
B1779171L0 FDA UDI
510(k) Number
K952006 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
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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Accu-Beam by Transamerican Technologies International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K952006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Transamerican Technologies International

Sources (1)

  • FDA UDI b383111d-b5be-44b0-ad03-573724d9903c 36 fields · synced Jun 9, 2026