# K251699: The Botticelli (Model: Athena)

- Pathway: 510(k) (Traditional)
- Applicant: Bellamia Technologies, Inc.
- Decided: Oct 8, 2025 after 128 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 674 ancestors in all.
No later device cites it as a predicate yet.
0 of 675 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234004: Medical diode laser systems (CHARISMA, REGAL), Reveal Lasers, Ltd. (2025) Summary page 5.
- K171009: LASEMD Laser System, Lutronic Corporation (2017) Summary page 5.
- K180508: Joule System, Sciton, Inc (2018) Summary page 5.

## Indications for use
1470 nm Laser: Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines. 1927 nm Laser: The Botticelli (Model: Athena) is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). 2910 nm Laser: The Botticelli (Model: Athena) with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle), such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Scar revision (including acne scars).

Source page: https://510kreport.com/device/K251699
Methodology: https://510kreport.com/methodology