FDA.reportPublic FDA data

HR

Primary DI
07290016681284
Brand
HR
Company
FORMATK SYSTEMS LTD
Model
FS60002
Catalog number
FS60002
Device description
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153566000
K160195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153566000Magma SystemFormatk Systems , Ltd.2016-04-06GEX
K160195000Forma System, Forma Light SystemFormatk Systems , Ltd.2016-04-15ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016681284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016681284072900166812847290016681284

GMDN Terms#

Term, Definition table
TermDefinition
Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532396673
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016681314PLGFS10009FS100092017-08-18
07290016681147iProElite CartFS10001-3FS10001-32024-10-20
07290016681093iProEliteFS10000-3FS10000-32024-10-15
07290016681086Sheerwave PlusIPLaser 360FS700202023-08-27
07290016681079DioBreezeFS80020FS800202021-06-25
07290016681031Magma SparkFS80000FS800002016-11-30
07290016681000FormaFS10000FS100002017-08-18
07290016681024MagmaFS70000FS700002017-08-18
07290016681048Magma Spark ProFS90000FS900002018-12-16
07290016681055Magma Spark PlusFS90000FS900002018-12-16
07290016681062AlphaFS90000FS900002018-12-16
07290016681130DioBreeze CartFS80023FS800232021-06-25
07290016681437HR-MiniFS80021FS800212021-06-25
07290016681444HR-MaxFS80022FS800222021-06-25
07290016681321ALDFS70001FS700012017-08-18
07290016681338NDFS70002FS700022017-08-18
07290016681345LLDFS70007FS70072017-08-18
07290016681017Forma LightFS60000FS600002017-08-18
07290016681123Magma Spark CartFS80001FS800012018-12-16
07290016681352S-430FS90011FS900112018-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019840428Silk'nSilkn Beauty Ltd.ONF2026-05-06
00810060831359Venus Versa PROVenus Concept Inc.ONF2026-04-15
06979922960010MICOWEYMicowey Medical Equipment (Guangxi) Co., LTDONF2026-04-08
00850055552555InBellaMax SystemInbella Medical IncONF2026-03-25
06975617994025MULTIFUNCTIONAL SERIESBEIJING HONKON TECHNOLOGIES CO., LTD.ONF2026-03-23
00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
00860009525146MediLightMEDICREATIONS LLCONF2026-02-11
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLONF2025-12-16
07290117772645Black Stellar XPL HPLUMENIS BE LTDONF2025-09-08
07290117772652Stellar XPL Module KitLUMENIS BE LTDONF2025-09-08
07290016633313Plus ApplicatorINMODE M.D LTDONF2025-07-27
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
06974851083014BVLASERNanjing Bestview Laser S&T Co.,Ltd.ONF2024-11-27
06976573489105BilensShanghai Bele Medical Technology Co., Ltd.ONF2024-11-24
07290016681093iProEliteFORMATK SYSTEMS LTDONF2024-10-15
06928258000891GSDShenzhen GSD Tech Co., Ltd.ONF2024-09-30
06977620360019ZHEONEHebei Zhemai Technology Co., Ltd.ONF2024-09-19
08034108512464PRISMADEKA M.E.L.A. SRLONF2024-09-17
07290019863144Lumecca PeakINMODE M.D LTDONF2024-08-15
07290019863151Lumecca PeakINMODE M.D LTDONF2024-08-15
00850033906004XLase PlusBIOTEC ITALIA SRLONF2024-07-29
0880970938041110PLTENTECH Inc.ONF2024-06-28
0880970938043510PLTENTECH Inc.ONF2024-06-28
00850062978003WORLD AESTHETIX BROAD PULSED LIGHTWORLD AESTHETIX LLCONF2024-06-25