FDA.reportPublic FDA data

XTRAC

Primary DI
010800002
Brand
XTRAC
Company
Strata Skin Sciences, Inc.
Model
AL 8000
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041943000XTRAC XL, MODEL AL8000Photo Medex, Inc.2004-10-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
010800002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological excimer laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power ultraviolet laser beam (UVA and/or UVB) intended for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Regulatory Flags#

DUNS number
618522536
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M709VTRAC01VTRACVTRAC2025-03-06
M709THCLR01TheraClearTC402025-03-06
M709AL100000XTRACAL100002024-05-14
010822602XTRACAL 8000 Ultra Plus2017-02-13
010822603XTRACAL 8000 Ultra Plus 7 Series2017-02-13
010800001XTRACAL 80002017-02-13
010800003XTRACAL 80002017-02-13
010800004XTRACAL 80002017-02-13
011000002XTRACAL10000 V4002017-02-13
011000004XTRACAL 10000 V400XL2017-02-13
011000005XTRACAL 10000 V7002017-02-13
011000006XTRACAL 10000 V700 XL2017-02-13
011000007XTRACAL 10000 V7 7 Series2017-02-13
011000008XTRACAL 10000 V400 XL 7 series2017-02-13
011000009XTRACAL 10000 V400 7 Series2017-02-13
00408919VTRAC100-120 Vac Non Credit2017-02-13
00408939VTRAC100-120 Vac Credit2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14