FDA.reportPublic FDA data

Intense Pulsed Light (IPL) System

Primary DI
06971008271034
Brand
Intense Pulsed Light (IPL) System
Company
Shenzhen Fansizhe Science And Technology Co., Ltd.
Model
T012C
Published
2022-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K212881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212881000Intense Pulsed Light (IPL) SystemShenzhen Fansizhe Science and Technology Co., Ltd.2022-04-11OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971008271034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971008271034069710082710346971008271034

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

Regulatory Flags#

DUNS number
417663470
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971008271263Intense Pulsed Light (IPL) SystemT033MW2024-06-07
06971008271225Intense Pulsed Light (IPL) SystemT002AW2023-09-20
06971008271232Intense Pulsed Light (IPL) SystemT002BW2023-09-20
06971008271249Intense Pulsed Light (IPL) SystemT033KW2023-09-20
06971008271089intense Pulsed Light (IPL) SystemT023K2023-04-14
06971008271096Intense Pulsed Light (IPL) SystemT023A2023-04-14
06971008271102Intense Pulsed Light (IPL) SystemT023B2023-04-14
06971008271119Intense Pulsed Light (IPL) SystemT023C2023-04-14
06971008271126Intense Pulsed Light (IPL) SystemT023D2023-04-14
06971008271133Intense Pulsed Light (IPL) SystemT023E2023-04-14
06971008271140Intense Pulsed Light (IPL) SystemT021K2023-04-14
06971008271157Intense Pulsed Light (IPL) SystemT021A2023-04-14
06971008271164Intense Pulsed Light (IPL) SystemT001A2023-04-14
06971008271171Intense Pulsed Light (IPL) SystemT001M2023-04-14
06971008271188Intense Pulsed Light (IPL) SystemT001B2023-04-14
06971008271195Intense Pulsed Light (IPL) SystemT001N2023-04-14
06971008271201Intense Pulsed Light (IPL) SystemT011C2023-04-14
06971008271218Intense Pulsed Light (IPL) SystemT016K2023-04-14
06971008271072Intense Pulsed Light (IPL) SystemT015A2023-04-07
06971008271041Intense Pulsed Light (IPL) SystemT013C2022-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06974667823057UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823064UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
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06974667822944UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-19
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