FDA.reportPublic FDA data

CONAIR

Primary DI
00074108504753
Brand
CONAIR
Company
CONAIR CORPORATION
Model
MASK4
Published
2024-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183247000dpl FacewareLed Technologies, Inc.2019-03-14OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10074108504750PackageGS12In Commercial Distribution
00074108504753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007410850475010074108504750
00074108504753000741085047530741085047530074108504753

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001661222
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00074108510389CONAIRHM29QL2024-11-18
00074108510396CONAIRHM29QW2024-11-18
00074108510402CONAIRHM29QB2024-11-18
00074108453488CONAIRHP08FX2024-10-07
00074108502674CONAIRHP512024-10-07
00074108246615ConairHP08T2023-07-07
00074108457868CONAIRHP122022-02-07
00074108448316CONAIR CORPORATIONHP08FW2021-03-30
00074108359469CONAIRHP08F2018-02-16
00074108477460CONAIRHM212024-08-12
00074108240699CONAIRNK17K2022-05-11
00074108295255CONAIRNM752022-05-11
00074108296047CONAIRNM75K2022-05-11
00074108297600CONAIRNM7SS2022-05-11
00074108314819CONAIRNM17KMT2022-05-11
00074108256775CONAIRNM122022-05-06
00039052019821Travel SmartTS12HP2024-05-23
00074108499714ConairWW750ZF2024-05-13
00074108319005ConairHM122024-04-03
00079642314868CONAIRA314862024-03-25

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10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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