FDA.reportPublic FDA data

Standard 64 Rejuvenation iD, (400 Pulse), Sterile

Primary DI
07290109951225
Brand
Standard 64 Rejuvenation iD, (400 Pulse), Sterile
Company
SYNERON MEDICAL LTD
Model
AS89512
Catalog number
AS89512
Device description
Standard 64 Rejuvenation iD, (400 Pulse), Sterile
Published
2016-09-22
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
07290109951225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109951225072901099512257290109951225

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
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26