FDA.reportPublic FDA data

Drx SpotLite

Primary DI
B347BA5674100
Brand
Drx SpotLite
Company
LED TECHNOLOGIES INC
Model
BA567410
Published
2019-07-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B347BA5674101PackageHIBCC3Not in Commercial Distribution
B347BA5674102PackageHIBCC8Not in Commercial Distribution
B347BA5674100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Regulatory Flags#

DUNS number
197386191
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B347202366010Dr Dennis Gross Skincare202366012026-04-23
B347202366020Dr Dennis Gross Skincare202366022026-04-23
B347202366030Dr Dennis Gross Skincare202366032026-04-23
B347BDRCK0Bedrock BioscienceBDRCK2026-04-23
B347BDRCKED0Bedrock BioscienceBDRCKED2026-04-23
B347F301SP0Hammacher Schlemmer‎F301SP2016-09-20
B347TB202400000TABTB2024-00002026-04-23
B347BBSPSFMFL180BLU0BedrockBBSPSFMFL180BLU2024-03-13
B347DPLPNLSYS0dpl®DPLPNLSYS2016-09-20
B347BA5681100Dr Dennis Gross SkincareBA5681102024-02-12
B347BA5682100Dr Dennis Gross SkincareBA5682102024-02-12
B347BA5706100Dr Dennis Gross SkincareBA5706102024-02-12
B347DPLNUVEPN0dpl®DPLNUVEPN2016-09-20
B347LTSRCE0Light Source Pain ReliefLTSRCE2017-12-11
B347RVPOOFB0reVive Light Therapy®RVPOOFB2018-01-23
B347RVPOOFW0reVive Light Therapy®RVPOOFW2018-01-23
B347VP5932801000Vanity PlanetVP5932801002019-11-23
B347VP5938800000Vanity PlanetVP5938800002024-03-13
B347RVACSPOT0reVive Light Therapy®RVACSPOT2017-03-10
B347RVACES0reVive Light Therapy®RVACES2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990198NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990204NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990211NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990228NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990334NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
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06978368600238DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
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00850523007365CellumaBiophotas, Inc.OLP2026-04-06
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07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
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06979826590177PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
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06979826590207PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
00858985006360EVRL-OTCERCHONIA CORPORATION, LLCOLP2026-02-09
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
06978368600108LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06