Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036803067

FEI Number

3036803067

Entity Name

INBELLA MEDICAL INC.

City/State/Country

Richmond Hill Ontario, CA

Establishment Address

100 Leek Crescent, unit 13, Richmond Hill Ontario L4B3E6, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Inbella Medical Inc. (Owner Number: 10092855)

Owner / Operator Contact Address

100 Leek Crescent, unit 13, Richmond Hill, CA-ON L4B3E6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250200

PMA Number

N/A

All Registered Proprietary Names

InBella EmPower System BellaMiniFX Applicator i-BellaForma Applicator Resurfacing (T) tip InBellaRF System BellaPlus Applicator 40-pin (Body) tip InBellaMulti System BellaM8 Body Applicator BellaFractora with 24 pins tip BellaWMFace Applicator BellaM8 Applicator InBellaRF Pro System BellaForma Applicator Prime (12-pin) tip BellaBodyFX Applicator BellaFractora with 60 pins tip BellaPlus90 Applicator and tip 24-pin tip NP102206D (Bella Turbo 10) Inbella RF System NP253966D (Bella Turbo 25) NP060909D (Bella060909) NP1022B6D (BellaQ10) NP101306D (Bella101306) NP2539B6D (BellaQ25) NP172206D (Bella172206) NP172248D (Bella172248) NP172246D (Bella172246) BellaM8 Resurf tip BellaM8 Burst handpiece Bella Turbo 25 (NP253966D) Bella Body (NP172296D) BellaM8 Body (40-pin) tip BellaM8 Burst (24 pin) tip Bella Turbo 10 (NP102206D) BellaQ10 (NP1022B6D) BellaM8 Burst Deep handpiece BellaM8 Prime (12 pin) tip InbellaIgnite RF System BellaQ25 (NP2539B6D) BellaAccu (NP060999D) Bella Face (NP101396D) InBellaBody system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-02-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-04-25

Official Correspondent

Michael Bank

US Agent Details

Ron HaCohen Email: ron.hacohen@inmodemd.com Phone: (949) 2751295

Related Public Records

Same Entity

Inbella Medical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036803067. Last updated year: 2026. Please use registration number 3036803067 when referencing this establishment in official correspondence.