FDA.reportPublic FDA data

LF2 applicator

Primary DI
07290016540048
Brand
LF2 applicator
Company
VENUS CONCEPT LTD
Model
AS100008
Device description
The Venus Legacy device is intended for the treatment of the following medical conditions; usingthe applicators for delivery of non-thermal RF combined with massage and magneticfield pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite
Published
2016-09-24
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
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143554000
K191528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143554000Venus Legacy CXVenus Concept , Ltd.2015-08-04PBX
K191528000Venus Legacy Pro DeviceVenus Concept USA, Inc.2019-09-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016540130PackageGS11In Commercial Distribution
07290016540048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016540130072900165401307290016540130
07290016540048072900165400487290016540048

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator, bipolarA bipolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes between the two tips of this device during treatment, and not through the patient to a return electrode. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533127663
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016540765Venus Legacy CX - LB2 applicator (new design)AS1000632018-11-18
07290016540963Venus Legacy CX - LF2 applicator (new design)AS1000752018-11-18
07290016541281BLISS SYSTEMBL0000012021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissSPK1600002021-07-14
07290016541618(MP)2 APPLICATOR BLISSAS1600432021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissSPK1600012021-07-14
07290016540000Venus LegacyLE1200042016-09-24
07290016540055Venus Legacy kitPK0000082016-09-24
07290016540079LB1 + LF1 kitPK0000412016-09-24
07290016540086Venus Legacy - 110V SystemLE1000042018-11-18
07290016540109Venus Legacy LE2400042016-09-24
07290016540116Venus Legacy kitPK0000022016-09-24
07290016541472Venus Legacy 240V - NikaoAS100005NI2018-11-18
07290016541533Venus Legacy 110V - NikaoLE120004NI2018-11-18
07290016541984Epileve Applicator Service Pack UDI LabelSPK2300102021-07-14
27290016541179HR 690XL Light Block packagePK0003242020-04-23
27290016541216HR690 Light Block packagePK0003282020-04-23
27290016541223ACDUAL Light Block packagePK0003442020-04-23
07290016541168Venus Versa - HR 650XL light block packagePK0003232018-11-18
07290016541182Venus Versa - SR515 light block packagePK0003252018-11-18

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