M22 IPL "VA" Filter

FDA UDI

Class II (US FDA UDI)

by Lumenis Be, Inc.

Identity

Trade Name: M22 IPL "VA" Filter FDA UDI
Generic Name: Dermatological laser beam guiding handpiece FDA UDI
Model / Reference: NA FDA UDI

Identifiers

Primary DI / UDI-DI: 07290117772201 FDA UDI
510(k) Number: K170060 FDA UDI
FDA Product Code: ONF FDA UDI
ONG FDA UDI
GEX FDA UDI
GMDN Term: Dermatological laser beam guiding 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

Category: Dermatological laser beam guiding handpiece

M22 IPL "VA" Filter by Lumenis Be, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K170060 also covers:

M22 IPL "AC" Filter — Lumenis Be, 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

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Manufacturer

Manufacturer: Lumenis Be, Inc.

Sources (1)

FDA UDI c9afdcd0-8431-427d-86a0-d5541002a35f 33 fields · synced May 30, 2026