Opus System 110V

FDA UDI

Class II (US FDA UDI)

by Alma Lasers Ltd.

Identity

Trade Name: Opus System 110V FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Model / Reference: 1 FDA UDI

Identifiers

Catalog Number: AASP12091701BA0001 FDA UDI
Primary DI / UDI-DI: 17290110121782 FDA UDI
FDA Product Code: IMI FDA UDI
ISA FDA UDI
GEI FDA UDI
NUV FDA UDI
GMDN Term: Multi-modality skin surface treatment system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5300 FDA UDI
890.5660 FDA UDI
878.4400 FDA UDI
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

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: Multi-modality skin surface treatment system Radio-frequency skin/body contouring system

Opus System 110V by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Alma Lasers Ltd.

Sources (1)

FDA UDI d4f97844-a114-493d-a227-8ca7811ed833 33 fields · synced May 31, 2026