FDA.reportPublic FDA data

STETIC SENSE

Primary DI
06970821120055
Brand
STETIC SENSE
Company
Stetic Medical Aesthetics Development (Shenzhen)Co.,Ltd.
Model
IPL-HQ3HU-SP
Published
2018-12-22
Public version status
Update
Distribution status
Not 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
16970821120052PackageGS14Not in Commercial Distribution
06970821120055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697082112005216970821120052
06970821120055069708211200556970821120055

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.

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
06970821120017STETIC SENSEIPL-380-IT 2017-03-31
06970821120024HOMEDICSIPL-HH3902017-03-31
06970821120031HOMEDICSIPL-HH1802017-03-31
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
06970453310022MONALIZABeijing Sincoheren S&T Development Co.,Ltd.ONF2026-09-24
06970453310039MONALIZABeijing Sincoheren S&T Development Co.,Ltd.ONF2026-09-24
06974639600464IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHT2026-08-27
06974639600471IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHT2026-08-27
06974639600488IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHT2026-08-27
06973011720158Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., LtdONF2026-08-07
06977357490171MlayShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06977357491314MlayShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06977357497941DREAMEShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06974028410001ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410018ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410032ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410087ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974667829554UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829561UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829578UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829608UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829615UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829622UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
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