FDA.reportPublic FDA data

Focal 44 Sublative iD, (100 Pulse,Red)

Primary DI
07290109950716
Brand
Focal 44 Sublative iD, (100 Pulse,Red)
Company
SYNERON MEDICAL LTD
Model
AS79264
Catalog number
AS79264
Device description
Focal 44 Sublative iD, (100 Pulse,Red)
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090025000MATRIX RF APPLICATORSyneron Medical, Ltd.2010-01-08GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37290109950717PackageGS110In Commercial Distribution
07290109950716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3729010995071737290109950717
07290109950716072901099507167290109950716

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532685716
Device count
1
Lot or batch
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13
08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12
00190776434083MillenniumAvalign Technologies, Inc.GEI2026-10-09
00190776434199MillenniumAvalign Technologies, Inc.GEI2026-10-09
B382SD030861101530Surgical DirectSurgical Direct, Inc.GEI2026-10-09
00190776436186MillenniumAvalign Technologies, Inc.GEI2026-10-08
00190776436544MilleniumAvalign Technologies, Inc.GEI2026-10-08
00190776436599MilleniumAvalign Technologies, Inc.GEI2026-10-08
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-08
00848657078504AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078511AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078528AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083805AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083904AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215397Disposable Bipolar Forceps, 9", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215403Disposable Bipolar Forceps, 9", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215410Disposable Bipolar Forceps, 9", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06