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Sr

FDA UDI

Class II (US FDA UDI)

by Formatk Systems Ltd

Identity

Trade Name
SR FDA UDI
Generic Name
Light-energy skin surface treatment system applicator FDA UDI
Device Name
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Pigmented Lesion treatments FDA UDI
Model / Reference
FS60001 FDA UDI
Description
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Pigmented Lesion treatments FDA UDI

Identifiers

Catalog Number
FS60001 FDA UDI
Primary DI / UDI-DI
07290016681307 FDA UDI
510(k) Number
K153566 FDA UDI
K160195 FDA UDI
FDA Product Code
ONF FDA UDI
GMDN Term
Light-energy skin surface treatment system applicator 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Light-energy skin surface treatment system applicator

Sr by Formatk Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K153566 also covers:

K160195 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Formatk Systems Ltd

Sources (1)

  • FDA UDI 8783fa94-85e2-4da8-ac8b-41b7ecb724cd 35 fields · synced May 29, 2026