Multi-Application Handpiece Set

FDA UDI

Class II (US FDA UDI)

by Lumenis

Identity

Trade Name: Multi-Application Handpiece Set FDA UDI
Generic Name: Surgical laser system beam-focus handpiece FDA UDI
Device Name: Additional DM UDI: 07290109144146 07290109144153 07290109144160 07290109144016 07290109144184 07290109144191 07290109144207 07290109144214 07290109144221 FDA UDI
Model / Reference: Multi-Application Handpiece Set FDA UDI
Description: Additional DM UDI: 07290109144146 07290109144153 07290109144160 07290109144016 07290109144184 07290109144191 07290109144207 07290109144214 07290109144221 FDA UDI

Identifiers

Catalog Number: AA2377300 FDA UDI
Primary DI / UDI-DI: 07290109141534 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Surgical laser system beam-focus handpiece 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical laser system beam-focus handpiece

Multi-Application Handpiece Set by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical laser system beam-focus handpiece.

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Accu-Beam — Transamerican Technologies International · Class II
Accu-Beam — Transamerican Technologies International · Class II
TrueSpot™ 2.0mm Handpiece — Lumenis Be, Inc. · Class II
Accu-Beam — Transamerican Technologies International · Class II
SurgiTouch™ Scanning Handpiece Set — Lumenis Be, Inc. · Class II

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: Lumenis

Sources (1)

FDA UDI 22e5ade8-052d-4032-9bec-798621e866e0 35 fields · synced May 30, 2026