FDA.reportPublic FDA data

SMOOTHSKIN

Primary DI
05060352780901
Brand
SMOOTHSKIN
Company
CYDEN LIMITED
Model
SmoothSkin BARE
Device description
Light Based Over-The-Counter Hair Removal
Published
2019-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHTLight Based Over-The-Counter Hair Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163552000iPulse SmoothSkin BARE Hair Removal DeviceCyden Limited2017-03-03OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060352781151PackageGS16Not in Commercial Distribution
05060352780901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060352781151050603527811515060352781151
05060352780901050603527809015060352780901

GMDN Terms#

Term, Definition table
TermDefinition
Home-use intense pulsed light hair removal unitA hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.

Contacts#

Phone, Email table
PhoneEmail
1-800-715-9522support-us@smoothskin.com

Regulatory Flags#

DUNS number
424832900
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060352783032SMOOTHSKINSmoothSkin Bare Fit2022-01-24
05060352783049SMOOTHSKINSmoothSkin Pure Fit2022-01-24
05060352783308SMOOTHSKINSmoothSkin Pure Mini2022-05-19
05060352783834SMOOTHSKINSmoothSkin Bare Fit2022-01-24
05060352783919SMOOTHSKINSmoothSkin Bare Fit2022-01-24
05060352783971SMOOTHSKINSmoothSkin Bare+2022-02-28
05060352785579SMOOTHSKINSmoothSkin Pure Adapt2024-03-06
05060352785593SMOOTHSKINSmoothSkin Pure Adapt2024-03-06
05060352783643SMOOTHSKINSmoothSkin Bare+2021-08-17
05060352785562SMOOTHSKINSmoothSkin Pure Adapt2024-03-06
05060352785586SMOOTHSKINSmoothSkin Pure Adapt2024-03-06
05060352782240SMOOTHSKINSmoothSkin Bare+2020-03-19
05060352780208SMOOTHSKINSmoothSkin GOLD 120k 2016-10-12
05060352780550SMOOTHSKINSmoothSkin GOLD 300k 2016-10-11
05060352782608SMOOTHSKINSmoothSkin Pure2020-06-22
05060352783964SMOOTHSKINSmoothSkin Bare+2022-02-28
05060352784329SMOOTHSKINSmoothSkin Pure Mini2022-05-19
05060352784145SMOOTHSKINSmoothSkin Bare+2022-02-28
05060352784176SMOOTHSKINSmoothSkin Bare+2022-02-28
05060352783544SMOOTHSKINSmoothSkin Bare Fit2022-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974667829738UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06974667829745UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06974667829752UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06956822893044GOODWINDShenzhen Goodwind technology development Co.,LtdOHT2026-04-23
06956822893051GOODWINDShenzhen Goodwind technology development Co.,LtdOHT2026-04-23
00047400703117Braun Silk.expert Pro 5PROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
00047400703230Braun Silk.expert Pro 5PROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
00047400703360Braun Skin i-expertPROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
06974667821442UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667821459UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822852UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822869UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822876UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822883UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822890UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822906UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822913UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822920UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822937UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823033UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823040UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823057UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823064UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823071UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826287UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826294UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826300UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826317UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826324UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826331UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23