FDA.reportPublic FDA data

BellaM8 B24Resurf Tip

Primary DI
00850055552579
Brand
BellaM8 B24Resurf Tip
Company
Inbella Medical Inc
Model
NG613051D
Device description
BellaM8 B24 Resurfacing Tip
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K251435000
K252215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251435000InbellaIgnite RF SystemInbella Medical, Inc.2026-01-27GEI
K252215000InbellaMAX SystemInbella Medical , Ltd.2025-07-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055552579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055552579008500555525798500555525790850055552579

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.

Regulatory Flags#

DUNS number
243330492
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00850055552586BellaM8 B12Prime TipNG613052D2026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28