InbellaMAX System

K252215 · Inbella Medical , Ltd. · GEI · Jul 25, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K252215
• Device Name: InbellaMAX System
• Applicant: Inbella Medical , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 25, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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. 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, truncaland 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 Story

InbellaMAX is a computerized, multi-energy system (Laser, IPL, RF) for dermatologic and aesthetic procedures. System utilizes various interchangeable applicators (BellaForma, BellaPlus, BellaM8, Bella515/580, BellaVlaze, BellaXL series) to deliver specific energy types based on clinical indication. Integrated water-cooling system (radiator, pump, fan, sensors) manages thermal output for laser/IPL applicators. Operated by clinicians in professional settings; system enables individual parameter adjustment via interface. Output energy facilitates hair removal, lesion treatment, muscle pain relief, or tissue coagulation. Benefits include versatile treatment options for diverse dermatologic conditions.

Clinical Evidence

No clinical data. Bench testing only, confirming compliance with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-2, 60601-2-22, 60601-2-57, and 60825 standards.

Technological Characteristics

Computerized system generating Laser, IPL, and RF energies. Includes water-cooling system (radiator, pump, fan, reservoir, deionizer, filter, temperature/flow sensors). Compatible with multiple specific applicators. Complies with IEC 60601 series and IEC 60825 standards.

Indications for Use

Indicated for hair removal/permanent hair reduction; treatment of benign pigmented epidermal lesions (dyschromia, melasma, freckles); treatment of benign cutaneous vascular lesions (angiomas, telangiectasias, port wine stains, rosacea, venous malformations); temporary relief of minor muscle aches/pain/spasms; temporary improvement of local blood circulation; dermatologic procedures requiring soft tissue coagulation/contraction or hemostasis. Use of Morpheus8 applicator >62 mJ/pin limited to Skin Types I-IV.

Regulatory Classification

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.

Predicate Devices

• Optimas MAX System (K251632)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

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

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K252215 - Jodi K. Scott
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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 ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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 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, truncaland 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. | |
| 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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." | |

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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
[e-mail]
T [phone]
F [phone]
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.

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- 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, truncaland 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

## 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.

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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.