FDA.reportPublic FDA data

VTRAC

Primary DI
M709VTRAC01
Brand
VTRAC
Company
Strata Skin Sciences, Inc.
Model
VTRAC
Device description
Excimer Lamp Phototherapy System
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K051428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051428000VTRAC EXCIMER LAMP SYSTEMPhoto Medex, Inc.2005-08-09GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M709VTRAC01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Free-standing multi-speciality photodynamic therapy/phototherapy unitA freestanding electrically-powered device designed to emit visible light to the skin for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as non-melanoma skin cancer, and for phototherapy applications (e.g., psoriasis, hypertension, diabetes, attention deficit) associated with many clinical specialties (e.g., musculoskeletal, cardiovascular, neurology, pulmonology, dermatology). It is a large chamber lined with light-emitting diodes (LED) and features a diagnostic module to monitor parameters (e.g. blood pressure, respiratory rate) and provide real-time feedback to inform treatment; It is intended for use by a healthcare professional.

Contacts#

Phone, Email table
PhoneEmail
7606023300QualityAssurance@strataskin.com

Regulatory Flags#

DUNS number
618522536
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M709THCLR01TheraClearTC402025-03-06
M709AL100000XTRACAL100002024-05-14
010822602XTRACAL 8000 Ultra Plus2017-02-13
010822603XTRACAL 8000 Ultra Plus 7 Series2017-02-13
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
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00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
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