PelleFirm 25MM HP, 3-pack

Primary DI
00841494108229
Brand
PelleFirm 25MM HP, 3-pack
Company
Cynosure, LLC
Model
P325PFHPU
Device description
PelleFirm 25MM HP, 3-pack
Published
2018-09-17
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
PBXMassager, vacuum, radio frequency induced heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132949000PELLEFIRMEllman International, Inc.2014-02-20PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494108229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494108229008414941082298414941082290841494108229

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator, monopolarA monopolar 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 from this device to an indifferent return electrode placed on the patient. 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
780318028
Device count
1
Lot or batch
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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Primary DI, Brand, Company table
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00850055552036BellaForma ApplicatorInbella Medical IncPBX2026-03-26
00850055552043BellaPlus ApplicatorInbella Medical IncPBX2026-03-26
00850055552067BellaMiniFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552470InBellaBody SystemInbella Medical IncPBX2026-03-25
00850055552555InBellaMax SystemInbella Medical IncPBX2026-03-25
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08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
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