FDA.reportPublic FDA data

Philips Lumea IPL

Primary DI
00075020107763
Brand
Philips Lumea IPL
Company
Philips Consumer Lifestyle B.V.
Model
BRI984
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
00075020107763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020107763000750201077630750201077630075020107763

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
00075020108425Philips Lumea IPLBRI9372025-07-18
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
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06977357490171MlayShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06977357491314MlayShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06977357497941DREAMEShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16