FDA.reportPublic FDA data

Alpha

Primary DI
07290016681062
Brand
Alpha
Company
FORMATK SYSTEMS LTD
Model
FS90000
Catalog number
FS90000
Device description
Multi-modality system supporting IPL (Intense Pulse Light) and Laser applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Vascular Lesions
Published
2018-12-16
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
GEXPowered Laser Surgical Instrument
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183307000Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems , Ltd.2018-12-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016681062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016681062072900166810627290016681062

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
07290016681000FormaFS10000FS100002017-08-18
07290016681024MagmaFS70000FS700002017-08-18
07290016681048Magma Spark ProFS90000FS900002018-12-16
07290016681055Magma Spark PlusFS90000FS900002018-12-16
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
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16