FDA.reportPublic FDA data

Forma

Primary DI
07290016681000
Brand
Forma
Company
FORMATK SYSTEMS LTD
Model
FS10000
Catalog number
FS10000
Device description
Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatmentssuch as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion
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
GFEBrush, Dermabrasion, Powered
ILYLamp, Infrared, Therapeutic Heating
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160195000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016681000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016681000072900166810007290016681000

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532396673
Device count
1
Serial number
true
Manufacturing date on label
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
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
07290016681369S-530FS90012FS900122018-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
00850051554003XSONXXSONX LLCGFE2026-07-09
08800102500345Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500352Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500369Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500376Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500383Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
08809851470145WavefacialWEERO Co., Ltd.PBX2026-06-22
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
08053782384136T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
08809455602829LHALA JETMETA SYSTEMS CO., LTD.GFE2026-04-23
08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
00860009854598OvationULTBody Balance System, LLCILY2025-10-30
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10