FDA.reportPublic FDA data

Diamondpolar applicator for Venus Freeze

Primary DI
07290016540178
Brand
Diamondpolar applicator for Venus Freeze
Company
VENUS CONCEPT LTD
Model
FRWWM71
Device description
Diamondpolar applicator is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin I-IV.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016540208PackageGS11In Commercial Distribution
07290016540178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016540208072900165402087290016540208
07290016540178072900165401787290016540178

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.

Regulatory Flags#

DUNS number
533127663
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016540260Venus Viva applicatorAS1120112018-11-18
07290016540321Venus Viva applicatorAS1100112016-09-24
07290016540390SR515 applicatorAS1200332016-09-24
07290016540420HR690 applicatorAS1200302016-09-24
07290016540437HR650XL applicatorAS1200602016-09-24
07290016540451ACDUAL applicatorAS1200582016-09-24
07290016540741Venus Viva - Diamondpolar applicatorAS1120102018-11-18
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
07290016541625BODY LASER APPLICATOR BLISSAS1600042021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissSPK1600012021-07-14
07290016541724Belt BlissAS1600272021-07-14
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
07290016540000Venus LegacyLE1200042016-09-24

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Primary DI, Brand, Company table
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B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
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08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16