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illuvinate System

FDA UDI

Class II (US FDA UDI)

by Luma Therapeutics

Identity

Trade Name
illuvinate System FDA UDI
Generic Name
Light-energy skin surface treatment system applicator FDA UDI
Model / Reference
CAT0581 FDA UDI

Identifiers

Primary DI / UDI-DI
00860228002107 FDA UDI
FDA Product Code
FTC FDA UDI
GMDN Term
Light-energy skin surface treatment system applicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Light-energy skin surface treatment system applicator

illuvinate System by Luma Therapeutics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Light-energy skin surface treatment system applicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Luma Therapeutics

Sources (1)

  • FDA UDI c33959cd-8509-4ecf-bf8c-883d75a11aea 32 fields · synced May 30, 2026