FDA.reportPublic FDA data

Lens, Gold & Silver

Primary DI
07290109950273
Brand
Lens, Gold & Silver
Company
SYNERON MEDICAL LTD
Model
AS92041
Catalog number
AS92041
Device description
Lens, Gold & Silver Assy, CO2RE
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K151655000
K181523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151655000CO2RE SystemSyneron Medical, Ltd.2015-09-15GEX
K181523000Syneron CO2RE SystemSyneron-Candela Corp2018-07-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109950273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109950273072901099502737290109950273

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological carbon dioxide laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532685716
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109952697SA Med. Repl. Cover 25x30mm, 4Hr, Velashape IIIAS83333AS833332017-06-01
07290109952703SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III AS87512AS875122017-06-01
17290109950416SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape IIIKT75061KT750612016-09-26
17290109950423SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIIKT75671KT756712016-09-26
17290109950430SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape IIIKT75071KT750712016-09-26
17290109952151LA Repl. Stacking Covers 8 Hr 5PkKT74831KT748312016-09-26
17290109952212LA Replaceable Cover (4 Hr) 5-PkKT75102KT751022016-09-26
37290109950342LA Repl. Cvr. (1Hr) 10-PkKT71745KT717452016-09-26
37290109950359SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II KT71751KT717512016-09-26
37290109950410SA Repl. Small Cvr. 10x13mm (4 Hr) 10-Pk, Velashape IIIKT7425AKT7425A2016-09-26
37290109950427SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 10-Pk, Velashape IIIKT75661KT756612016-09-26
37290109950434SA Repl. Med. Cvr. 25x30mm (4 Hr) 10-Pk, Velashape IIIKT7426AKT7426A2016-09-26
37290109952162LA Repl. Stacking Covers (16 Hr) 10-PkKT74841KT748412016-09-26
07290109950242VelaShape systemFG00131FG001312016-09-20
07290109950259Vsmooth ApplicatorFG00101FG001012016-09-20
07290109950266Vcontour Applicator FG00111FG001112016-09-20
07290109950303Vela Shape II systemFG70321FG703212016-09-20
07290109950310Vela Shape II systemFG70331FG703312016-09-20
07290109950327Vsmooth ApplicatorFG70341FG703412016-09-20
07290109950334Vcontour ApplicatorFG70351FG703512016-09-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
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
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