The InbellaMAX System with the BellaXL 810 Black is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The BellaXL 755/810 Black and the BellaXL 810/1064 Black are intended for hair removal.

The InbellaMAX System with the BellaVlaze Black is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

The InbellaMAX System with the Bella515 and Bella580 Black Applicators are indicated for use for the following treatments:

The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.

The InbellaMAX System with the BellaPlus and BellaForma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The InbellaMAX System with the BellaM8 BApplicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

Device Description

The InbellaMAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. The system is compatible with the following applicators:

BellaForma
BellaPlus
BellaM8 BApplicator and BellaM8 BDeep Applicators
Bella515 Black
Bella580 Black
BellaVlaze Black
BellaXL 755/810 Black
BellaXL 810/1064 Black
BellaXL 810 Black

AI/ML Overview

Based on the provided FDA 510(k) Clearance Letter for the InbellaMAX System, it's important to understand that this document primarily focuses on Substantial Equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a test set.

The core essence of this 510(k) submission is that the InbellaMAX System is identical in all aspects to the predicate device (Optimas MAX System, K251632) except for the manufacturer and 510(k) holder. This means that the acceptance criteria and the proof of meeting those criteria would have been established and demonstrated for the predicate device, and the InbellaMAX System is simply asserting equivalence based on its identical design and function.

Therefore, the information typically found in a performance study with explicit acceptance criteria for a new, novel device is largely absent here because it's a "copy" of an already cleared device. The "study" proving it meets acceptance criteria is the demonstration that its design, technology, and intended use are identical to the predicate.

Given this, I will answer your questions as best as possible based on the provided text, highlighting where information is absent due to the nature of a substantial equivalence claim for an identical device.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Logic)

Since the device is declared "identical in all aspects" to the predicate, the "acceptance criteria" for the InbellaMAX System are implicitly that it performs exactly like the predicate device, meeting all the performance standards the predicate device met. The "reported device performance" is, by definition, the performance of the predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (Implied from Predicate Equivalence)
Functional Performance: Functions as a computerized system generating Laser, IPL, and RF energies for intended dermatologic procedures.	Confirmed: The InbellaMAX system is a computerized, versatile system that generates Laser, IPL, and RF energies. It utilizes different applicators to achieve its mode of operation.
Applicator Compatibility: Compatible with specified applicators (BellaForma, BellaPlus, BellaM8 BApplicator, BellaM8 BDeep Applicators, Bella515 Black, Bella580 Black, BellaVlaze Black, BellaXL 755/810 Black, BellaXL 810/1064 Black, BellaXL 810 Black).	Confirmed: The system is compatible with the listed applicators (Page 6).
Cooling System Functionality: Water-cooling system provides cooling for laser/IPL applicators and TECs, including radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor.	Confirmed: The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes all mentioned components (Page 6).
Adherence to Voluntary Recognized Standards: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2, IEC 60601-2-22, IEC 60601-2-57, IEC 60825.	Confirmed: The InbellaMAX System has been tested and complies with all listed voluntary recognized standards (Page 7).
Safety and Effectiveness: Functions as safely and effectively as the predicate device for all stated Indications for Use.	Implied by Substantial Equivalence: "identical in all aspects... The only difference is the manufacturer and 510(k) holder." (Page 5) and "Except for the difference in device name and applicator names, the indications for use of the subject device are identical to those of the predicate device. The technological characteristics of the subject device are identical to those of the predicate device." (Page 6).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable/Not provided. No separate clinical or non-clinical test set data specific to the InbellaMAX system is presented because the submission relies on substantial equivalence. The "test set" for the original predicate device (Optimas MAX System, K251632) would have been used to establish its safety and effectiveness, and the InbellaMAX System is declared identical.
Data Provenance: Not applicable/Not provided. The document does not refer to any new test data for the InbellaMAX System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This information pertains to the rigorous evaluation of a new device's performance, typically involving clinical trials or extensive non-clinical testing. For a substantial equivalence claim based on identical design, such details are not required for the subject device. This would have been part of the predicate device's clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. As no new test set is described, no adjudication method is referenced. This would have pertained to the predicate device's evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This type of study (MRMC, AI assistance) is not relevant to this device, which is a laser/IPL/RF system for dermatologic procedures, not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This term typically applies to AI algorithms. The InbellaMAX System is a hardware-based medical device. Its "performance" is its ability to generate laser/IPL/RF energy and function as intended, rather than producing an "output" like an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided. No new "ground truth" was established for the InbellaMAX system, as it's a substantial equivalence claim based on an identical predicate device. The clinical effectiveness and safety of the predicate device would have been established through relevant data, which could have included clinical outcomes, expert observations, and other performance metrics depending on the specific indications.

8. The sample size for the training set

Not applicable/Not provided. This term typically applies to machine learning models. The InbellaMAX System is a hardware device; it does not have a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, this concept refers to machine learning models, which is not applicable to the InbellaMAX System.

Summary

FDA 510(k) Clearance Letter - InbellaMAX System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 25, 2025

Inbella Medical Inc.
℅ Jodi K. Scott
Partner
Hogan Lovells US LLP
1601 Wewatta Street
Suite 900
Denver, Colorado 80202

Re: K252215
Trade/Device Name: InbellaMAX System
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX, GEI, ONF, PBX
Dated: July 15, 2025
Received: July 15, 2025

Dear Jodi K. Scott:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K252215 - Jodi K. Scott Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252215 - Jodi K. Scott Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.07.25 13:29:37 -04'00'

for Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252215

Device Name: InbellaMAX System

Indications for Use (Describe)

The InbellaMAX System with the Bella515 and Bella580 Black Applicators are indicated for use for the following treatments:

The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

K252215 - 510(k) Summary Inbella Medical Inc.'s InbellaMAX System

Applicant Name:

Company Name: Inbella Medical Inc.

Address: 100 Leek Crescent, Unit 13
Richmond Hill
Ontario, Canada

Contact Person: Jodi K. Scott
Partner
jodi.scott@hoganlovells.com
T +1 303 454 2463
F +1 303 899 7333

Date Prepared: July 11, 2025

Name of Device: InbellaMAX System

Classification Name: Electrosurgical cutting and coagulation device and accessories

Regulation Number: 878.4400

Product Code: GEX, GEI, ONF, PBX

Predicate Device:

The InbellaMAX System manufactured by Inbella Medical is substantially equivalent to the Optimas MAX System cleared in K251632 by InMode Ltd.

Purpose of the 510(k) notice:

The device manufactured by Inbella Medical is identical in all aspects to the listed predicate device. The only difference is the manufacturer and 510(k) holder.

Intended Use:

The InbellaMAX System with the BellaXL 810 Black is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The BellaXL 755/810 Black and the BellaXL 810/1064 Black are intended for hair removal.
The InbellaMAX System with the BellaVlaze Black is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

Page 6

The InbellaMAX System with the Bella515 and Bella580 Black Applicators are indicated for use for the following treatments:
- The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.
The InbellaMAX System with the BellaPlus and BellaForma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The InbellaMAX System with the BellaM8 BApplicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

Device Description:

BellaForma
BellaPlus
BellaM8 BApplicator and BellaM8 BDeep Applicators
Bella515 Black
Bella580 Black
BellaVlaze Black
BellaXL 755/810 Black
BellaXL 810/1064 Black
BellaXL 810 Black

Substantial Equivalence

Indications for Use Comparison: Except for the difference in device name and applicator names, the indications for use of the subject device are identical to those of the predicate device.

Technological Comparison: The technological characteristics of the subject device are identical to those of the predicate device.

Page 7

Performance Standards:

The InbellaMAX System has been tested and complies with the following voluntary recognized standards:

IEC 60601-1: 2005/(R)2012 & A1:2012 C1: 2009/(R)2012
IEC 60601-1-2: 2020-09 Consolidated Version
IEC 60601-1-6: 2020-07 Consolidated Version
IEC 60601-2-2: 2017-03
IEC 60601-2-22: 2019-11
IEC 60601-2-57: 2011-01
IEC 60825: 2007-03

Non-Clinical (Bench) Performance Data:

Not Applicable

Animal Performance Data / Histology Data:

Not Applicable

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

Consequently, it can be concluded that the InbellaMAX System is substantially equivalent to the predicate InMode OptimasMAX System - K251632.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.