FDA.reportPublic FDA data

ketrina

Primary DI
06975587680010
Brand
ketrina
Company
Hunan Guangye Biotechnology Co., Ltd.
Model
KFB265
Published
2022-07-25
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221151000Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.2022-07-19OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975587680010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975587680010069755876800106975587680010

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
404145347
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975587680034NoodKCA4232022-11-01
06975587680003NoodKCA4232022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06979826590191PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
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
06978368600160LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06