FDA.reportPublic FDA data

SIBERIAN-FIT

Primary DI
07898961835082
Brand
SIBERIAN-FIT
Company
VYDENCE MEDICAL
Model
17613
Catalog number
17613
Device description
SIBERIAN-FIT
Published
2024-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K172439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172439000Siberian FitVydence2018-02-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961835082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961835082078989618350827898961835082

GMDN Terms#

Term, Definition table
TermDefinition
Localized cutaneous/musculoskeletal cryotherapy unitAn electrically-powered unit intended to create a stream of cold air/vapour (e.g., liquid nitrogen) for application to the skin surface for various localized therapeutic applications such as relief of underlying musculoskeletal symptoms (e.g., pain, spasm, inflammation, bruising), reduction of dermal pain/inflammation, and/or reduction of thermal skin damage during dermatological laser treatments. In addition to the main unit it may include a hose and spray-producing nozzle.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+551633065050sac@vydence.com

Regulatory Flags#

DUNS number
904013281
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898786930030ZYE-ULTRA FDA31303313032026-02-18
07898786930047ONE FDA31304313042026-02-18
07898961835426handPICO26378263782025-01-21
07898961835013ETHEREA-MX18057180572024-05-27
07898961835020IPL-Sq18077180772024-05-27
07898961835037LongPulse18085180852024-05-27
07898961835044ProDeep20746207462024-05-27
07898961835051GoSmooth18097180972024-05-27
07898961835068DualMode20744207442024-05-27
07898961835099intenseIR18073180732024-05-27
07898961835204ZYE YAG25705257052024-05-27
07898961835211ZYE ALX25704257042024-05-27
078989618352283-10/vl21799217992024-05-27
078989618352353-24/hr21806218062024-05-27
078989618352425-15/lt21803218032024-05-27
078989618352598-18/hr21805218052024-05-27
07898961835266handPICO27185271852024-05-27
07898961835075ACROMA-QS18098180982024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
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
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00850064466027FREDDOFABINJECT LLCGEX2024-10-28
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
00860007603761Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16
00860007603747Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16