FDA.reportPublic FDA data

SURGITRON 4.0 DUAL RF/90 IEC 220-240V

Primary DI
00841494108472
Brand
SURGITRON 4.0 DUAL RF/90 IEC 220-240V
Company
Cynosure, LLC
Model
IEC3A-S30-90/220
Device description
SURGITRON 4.0 DUAL RF/90 IEC 220-240V
Published
2019-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K013255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013255000SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RFEllman Intl., Inc.2001-11-07GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494108472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494108472008414941084728414941084720841494108472

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21

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