FDA.reportPublic FDA data

XTRAC

Primary DI
010822603
Brand
XTRAC
Company
Strata Skin Sciences, Inc.
Model
AL 8000 Ultra Plus 7 Series
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
010822603PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitrogen refillable cylinderA container designed as a refillable cylinder used to hold compressed nitrogen (N2) under safe conditions at high pressure (e.g., 50 - 150 Bar). It is typically filled with nitrogen when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote nitrogen content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the nitrogen at the correct working pressure. Nitrogen is typically used as a drive gas for surgical power tools (e.g., drills, reamers, saws) but can also be used in the clinical laboratory.

Sterilization Methods#

Method table
Method

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
010800001XTRACAL 80002017-02-13
010800002XTRACAL 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

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Primary DI, Brand, Company table
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04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
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07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
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06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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