FDA.reportPublic FDA data

BellaFractora24C Tip

Primary DI
00850055552050
Brand
BellaFractora24C Tip
Company
Inbella Medical Inc
Model
NG604108D
Device description
BellaFractora24C Tip
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K252367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252367000InbellaMulti SystemInbella Medical, Inc.2025-10-15GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055552050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055552050008500555520508500555520500850055552050

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator tipA removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
243330492
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055552005BellaBodyFX ApplicatorNG601654DNG600874D2026-03-26
00850055552067BellaMiniFX ApplicatorNG601654DNG604696D2026-03-26
00850055552494BellaTform ApplicatorNG609899D2026-04-02
00850055552630Bella515 Black ApplicatorNG613075D2026-04-02
00850055552647Bella580 Black ApplicatorNG613077D2026-04-02
00850055552654BellaVlaze Black ApplicatorNG613079D2026-04-02
00850055552661BellaXL 755/810 Black ApplicatorNG613088D2026-04-02
00850055552678BellaXL 810/1064 Black ApplicatorNG613089D2026-04-02
00850055552685BellaXL 810 Black ApplicatorNG613090D2026-04-02
00850055552104Bella060909 HandpieceNP060909D2026-03-31
00850055552111Bella101306 HandpieceNP101306D2026-03-31
00850055552128Bella Turbo 10 HandpieceNP102206D2026-03-31
00850055552142Bella172206 HandpieceNP172206D2026-03-31
00850055552159Bella172246 HandpieceNP172246D2026-03-31
00850055552173Bella Turbo 25 HandpieceNP253966D2026-03-31
00850055552203BellaM8 B24 TipNG613054D2026-03-31
00850055552210BellaM8 B40Body TipNG613053D2026-03-31
00850055552296BellaM8 B ApplicatorNG613055D2026-03-31
00850055552364InBella Multi System (InBellaEmPower)NG604881DNG609933D2026-03-31
00850055552579BellaM8 B24Resurf TipNG613051D2026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
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