FDA.reportPublic FDA data

Sensilight Pro - bronze

Primary DI
05060445341576
Brand
Sensilight Pro - bronze
Company
EL GLOBAL TRADE LTD
Model
IPL300US04SNS
Device description
The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair.Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured 6, 9 and 12 months after the completion of treatment regimen.
Published
2020-11-08
Public version status
Update
Distribution status
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
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183260000Sensilight Pro / Pistol IPLEl Global Trade, Ltd.2019-03-18OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060445341576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060445341576050604453415765060445341576

GMDN Terms#

Term, Definition table
TermDefinition
Intense pulsed light skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-736-7422support@sensica.com

Regulatory Flags#

DUNS number
649726981
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060445341255SensiliftST100US04SNS2017-12-07
05060445341569Sensilight Mini - bronzeIPL030US05SNS2020-11-05
05060445340005SensiLight - grey IPL050US01SNS2016-10-19
05060445340012SensiLight - mintIPL050US03SNS2016-10-19
05060445340029SensiLight - salmonIPL050US02SNS2016-10-19
05060445340043SensiLight Mini - mintIPL030US01SNS2016-10-19
05060445340050SensiLight Mini - blueIPL030US02SNS2016-10-19
05060445341309Sensifirm - bronzeCEL100US04SNS2020-11-05
05060445341118sensiFirmCEL100US01SNS2017-08-16
05060445341125sensiLiftST100US01SNS2017-08-16

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
00810060831359Venus Versa PROVenus Concept Inc.ONF2026-04-15
00850055552555InBellaMax SystemInbella Medical IncONF2026-03-25
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
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
06974667822944UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-19
06974667824139UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-17