LightSheer® Duet ET™ Handpiece

FDA UDI

Class II (US FDA UDI)

by Lumenis Be, Inc.

Identity

Trade Name: LightSheer® Duet ET™ Handpiece FDA UDI
Generic Name: Dermatological laser beam producing handpiece FDA UDI
Model / Reference: NA FDA UDI

Identifiers

Primary DI / UDI-DI: 07290117771044 FDA UDI
510(k) Number: K170179 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological laser beam producing 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 producing handpiece

LightSheer® Duet ET™ Handpiece 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

K170179 also covers:

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 3d0d985b-6c74-4dc3-af60-42f54c79378e 33 fields · synced May 31, 2026