FDA.reportPublic FDA data

HOMEDICS

Primary DI
06970821120031
Brand
HOMEDICS
Company
Stetic Medical Aesthetics Development (Shenzhen)Co.,Ltd.
Model
IPL-HH180
Published
2017-03-31
Public version status
Update
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
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
K161565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161565000DUOStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd2016-09-01ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970821120038PackageGS14Not in Commercial Distribution
06970821120031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697082112003816970821120038
06970821120031069708211200316970821120031

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544464442
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970821120048STETIC SENSEIPL-HG1HU-SP2018-12-22
06970821120055STETIC SENSEIPL-HQ3HU-SP2018-12-22
06970821120017STETIC SENSEIPL-380-IT 2017-03-31
06970821120024HOMEDICSIPL-HH3902017-03-31
16970821120045STETIC SENSEIPL-HG1HU-SP2018-12-22
16970821120052STETIC SENSEIPL-HQ3HU-SP2018-12-22

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
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