LaseMD Ultra

FDA UDI

Class II (US FDA UDI)

by Lutronic Corporation

Identity

Trade Name: LaseMD Ultra FDA UDI
Generic Name: Dermatological solid-state laser system FDA UDI
Device Name: Patient goggle FDA UDI
Model / Reference: Metal goggle/Spring FDA UDI
Description: Patient goggle FDA UDI

Identifiers

Primary DI / UDI-DI: 08809447653181 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological solid-state laser system 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dermatological solid-state laser system

LaseMD Ultra by Lutronic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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GMAX Pro Plus Laser System — Candela Corporation · Class II

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: Lutronic Corporation

Sources (1)

FDA UDI 1399ef33-2700-476f-8b5f-8a54ce4b9d51 34 fields · synced May 30, 2026