FDA.reportPublic FDA data

Sapphire X

Primary DI
00850001456203
Brand
Sapphire X
Company
Omm Imports Inc.
Model
SX100
Device description
Over the Counter Blue LED device for the treatment of acne.
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
OTC
true

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
00850001456203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001456203008500014562038500014562030850001456203

GMDN Terms#

Term, Definition table
TermDefinition
Blue-light phototherapy lamp, home-useA hand-held, battery-powered device designed to emit blue light (e.g., 400-450nm) for phototherapy applications to treat skin diseases such as acne, rosacea, and psoriasis by the patient in the home. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010000704
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001456784MODEL S+ BY SPIRULUX S9002026-05-03
00850001456791PRO MED BY JOUVALLE J9002026-05-02
00850001456746Quantum Q12026-03-02
00850001456739Elevare ONEE900 2025-12-01
00850001456357RelaxatioRX1002022-06-30
00850001456548Perfectio X G2G2-PX2024-10-28
00850001456524Genesis PrimeGP1002024-08-28
00850001456531GlorificoGL222024-08-28
00850001456555Glorifico PlusGL22+2024-08-28
00850001456647Genesis SkyeGSKYE2024-08-28
00850001456678ElevareE8002024-08-28
00850001456685Elevare PlusE7502024-08-28
00850001456692Elevare IvoryE5002024-08-28
00850001456708RevvE550R2024-08-28
00850001456715SpiruluxSP8002024-08-28
00850001456456Genesis ZGZ1002022-07-29
00850001456036Perfectio XPX1002022-06-30
00850001456067RecreoR2002022-06-30
00850001456111Juvenis J700B-S2022-06-30
00850001456128JuvenisJ700B-B2022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
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
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OLP2026-03-26
07640260120600FAQ LED PanelForeo ABOLP2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
06979826590115PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590122PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590139PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590146PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590153PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590160PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590177PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590184PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26