FDA.reportPublic FDA data

SMOOTHSKIN

Primary DI
05060352785586
Brand
SMOOTHSKIN
Company
CYDEN LIMITED
Model
SmoothSkin Pure Adapt
Device description
Light based Over-The-Counter Hair Removal
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060352785586PackageGS16In Commercial Distribution
05060352785593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060352785586050603527855865060352785586
05060352785593050603527855935060352785593

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
424832900
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
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
05060352782240SMOOTHSKINSmoothSkin Bare+2020-03-19
05060352780208SMOOTHSKINSmoothSkin GOLD 120k 2016-10-12
05060352780901SMOOTHSKINSmoothSkin BARE2019-10-14
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
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
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