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Philips Lumea IPL

FDA UDI

Class II (US FDA UDI)

by Philips Consumer Lifestyle B.V.

Identity

Trade Name
Philips Lumea IPL FDA UDI
Generic Name
Home-use intense pulsed light hair removal unit FDA UDI
Model / Reference
BRI931 FDA UDI

Identifiers

Primary DI / UDI-DI
00075020108494 FDA UDI
510(k) Number
K243453 FDA UDI
FDA Product Code
OHT FDA UDI
GEX FDA UDI
GMDN Term
Home-use intense pulsed light hair removal unit 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Home-use intense pulsed light hair removal unit

Philips Lumea IPL by Philips Consumer Lifestyle B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use intense pulsed light hair removal unit.

Cleared under the same submission

K243453 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Consumer Lifestyle B.V.

Sources (1)

  • FDA UDI 485f07cd-bb70-4de9-bc55-4a8af8067e1d 34 fields · synced Sep 18, 2026