FDA.reportPublic FDA data

Philips Lumea IPL

Primary DI
00075020108425
Brand
Philips Lumea IPL
Company
Philips Consumer Lifestyle B.V.
Model
BRI937
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
OHTLight Based Over-The-Counter Hair Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243453000Philips Lumea IPLPhilips Consumer Lifestyle B.V.2025-02-10OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075020108425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020108425000750201084250750201084250075020108425

GMDN Terms#

Term, Definition table
TermDefinition
Home-use intense pulsed light hair removal unitA hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
489122720
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075020120335Philips Lumea IPLBRC3442026-06-05
00075020120410Philips Lumea IPLBRC3322026-06-05
00075020107763Philips Lumea IPLBRI9842025-07-18
00075020108487Philips Lumea IPLBRI9322025-07-18
00075020108494Philips Lumea IPLBRI9312025-07-18
00075020109453Philips Avent Manual Breast PumpSCF430/03SCF430/032023-12-05
00075020107756Philips Avent Double Electric Breast PumpSCF393/82SCF393/822023-08-31
00075020070074Philips Avent Single Electric Breast PumpSCF332/21SCF332/212017-09-17
00075020070081Philips Avent Double Electric Breast PumpSCF334/22SCF334/222017-09-17
00075020070098Philips Avent Double Electric Breast Pump, Bottle & Brush setSCF334/23SCF334/232017-09-17
00075020070104Philips Avent Double Electric Breast PumpSCF334/25SCF334/252017-09-17
00075020070111Philips Avent Double Electric Breastfeeding setSCF334/26SCF334/262017-09-17
00075020060594Philips Avent Breast PumpSCF3342017-09-25
00075020063816Philips Avent Breast Pump SingleSCF3322016-09-17
00075020063823Philips Avent Breast Pump DoubleSCF3342016-09-17
00075020063830Philips Avent Breast PumpSCF3342016-09-17
00075020063847Philips Avent Breast PumpSCF3342016-09-17
00075020065803Philips Avent Breast PumpSCF3342016-09-17
00075020107770Philips Avent Double Breast Pump KitSCF338/52SCF338/522023-06-27
00007502005175Philips PulseReliefPR38412016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974028410001ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410018ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410032ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410087ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
06974667829554UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829561UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829578UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829608UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829615UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829622UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
06974667829738UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06974667829745UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27