Hand-held IPL device (IPL Home Use Hair Removal Device)

Primary DI
06973071101003
Brand
Hand-held IPL device (IPL Home Use Hair Removal Device)
Company
Shenzhen IONKA Medical Technology Co., Ltd.
Model
FZ-100
Device description
IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K230739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230739000Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200Shenzhen Ionka Medical Technology Co., Ltd.2023-05-26OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973071101003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973071101003069730711010036973071101003

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
707411576
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973071102000Hand-held IPL device (IPL Home Use Hair Removal Device)FZ-2002023-08-01
06973071106084Hand-held IPL device (IPL Home Use Hair Removal Device)FZ-6082023-08-01
06973071106183Hand-held IPL device (IPL Home Use Hair Removal Device)FZ-608G2023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
06974667829738UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
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00047400703360Braun Skin i-expertPROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
06974667821442UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
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06974667822920UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23