VersaCut+ Blade Set

FDA UDI

Class II (US FDA UDI)

by Lumenis

Identity

Trade Name: VersaCut+ Blade Set FDA UDI
Generic Name: Tissue morcellation system FDA UDI
Model / Reference: VersaCut+ Blade Set FDA UDI

Identifiers

Primary DI / UDI-DI: 07290109142494 FDA UDI
510(k) Number: K133272 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Tissue morcellation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Tissue morcellation system

VersaCut+ Blade Set by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tissue morcellation system.

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MultiCut Solo — Asclepion Laser Technologies GmbH · Class II
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BLUEENDO — TROKAMED GmbH · Class II
BLUEENDO — TROKAMED GmbH · Class II
TruClear — Covidien LP · Class II
NICO Myriad — NICO Corporation · Class II

Cleared under the same submission

K133272 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

Sources (1)

FDA UDI fa5c084e-13eb-4707-9398-8baa9af9d518 34 fields · synced May 29, 2026