Manufacturer
Inbella Medical, Inc.InbellaMAX System
Country / Region:Canada (CA)Submission type:Special
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252215
- Device name
- InbellaMAX System
- Company
- Inbella Medical, Inc.
- Country / Region
- Canada(CA)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-07-15
- Decision date
- 2025-07-25
- Submission type
- Special
- Technology type
- Energy Device(AI inferred)
- Clinical applications
- Other
- Primary application
- Other
- Classification source
- AI classified
Indications for 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, 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.
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, 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
Summary parsed at:2026-06-20 17:50:40 UTC
Predicate devices
1Optimas MAX System
K252215 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252215 as a predicate
