FDA.reportPublic FDA data

cosytime

Primary DI
16977603320037
Brand
cosytime
Company
Ningbo Dechang Electrical Machinery Made Co.,Ltd.
Model
RT01
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K242068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242068000LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd2025-04-04OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16977603320037PackageGS14In Commercial Distribution
06977603320030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697760332003716977603320037
06977603320030069776033200306977603320030

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
544874472
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977603320030cosytimeRT012025-11-28
06977603320023SUNVIVIRT012025-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
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00860016300309LMNTXPLR LTDOLP2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00810140063090RenphoJoicom CorporationOLP2026-06-23
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