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IPL Hair removal

FDA UDI

Class II (US FDA UDI)

by Shenzhen Weikai Technology Co., Ltd

Identity

Trade Name
IPL Hair removal FDA UDI
Generic Name
Cosmetic red-light phototherapy system, home-use FDA UDI
Device Name
The device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair. FDA UDI
Model / Reference
V201 FDA UDI
Description
The device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair. FDA UDI

Identifiers

Primary DI / UDI-DI
06970527070012 FDA UDI
510(k) Number
K203510 FDA UDI
FDA Product Code
OHT FDA UDI
GMDN Term
Cosmetic red-light phototherapy system, home-use 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cosmetic red-light phototherapy system, home-use

IPL Hair removal by Shenzhen Weikai Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cosmetic red-light phototherapy system, home-use.

Cleared under the same submission

K203510 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Weikai Technology Co., Ltd

Sources (1)

  • FDA UDI 63f4b041-cc98-483f-b95d-a10a785abffb 35 fields · synced Jun 1, 2026