UltraSlim Digital

FDA UDI

Class II (US FDA UDI)

by Photonica USA LLC

Identity

Trade Name: UltraSlim Digital FDA UDI
Generic Name: Low-intensity laser fat liquefaction system FDA UDI
Device Name: UltraSlim Digital, Red Light (635nm) FDA UDI
Model / Reference: 60008 FDA UDI
Description: UltraSlim Digital, Red Light (635nm) FDA UDI

Identifiers

Catalog Number: 60008 FDA UDI
Primary DI / UDI-DI: 00860925000338 FDA UDI
510(k) Number: K202361 FDA UDI
FDA Product Code: OLI FDA UDI
GEX FDA UDI
ILY FDA UDI
GMDN Term: Low-intensity laser fat liquefaction system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5400 FDA UDI
878.4810 FDA UDI
890.5500 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: Low-intensity laser fat liquefaction system

UltraSlim Digital by Photonica USA LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202361 also covers:

UltraSmooth Digital — Photonica USA LLC

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: Photonica USA LLC

Sources (1)

FDA UDI d2325978-8e6b-41ff-bbe5-201c8d33cb67 35 fields · synced Jun 1, 2026