Stellar Optima™

FDA UDI

Class II (US FDA UDI)

by Lumenis

Identity

Trade Name: Stellar Optima™ FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Model / Reference: Stellar Optima™ FDA UDI

Identifiers

Primary DI / UDI-DI: 07290109144641 FDA UDI
510(k) Number: DEN200028 FDA UDI
K193500 FDA UDI
FDA Product Code: GEX FDA UDI
ONF FDA UDI
ONG FDA UDI
QIU FDA UDI
GMDN Term: Multi-modality skin surface treatment system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
886.5201 FDA UDI
Commercial Distribution: Not 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

Stellar Optima™ by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

DEN200028 also covers:

K193500 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 7ab42c14-4025-4583-af6b-4a62f1da6d19 34 fields · synced May 30, 2026