Manufacturer
Bellamia Technologies, Inc.The Botticelli (Model: Athena)
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251699
- Device name
- The Botticelli (Model: Athena)
- Company
- Bellamia Technologies, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-02
- Decision date
- 2025-10-08
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Skin resurfacingPigment treatmentVascular treatmentAcne treatment
- Primary application
- Skin resurfacing
- Classification source
- AI classified
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).
Intended 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).
Device Description
The Botticelli (Model: Athena) is a Laser Powered Surgical Device classified as a Powered Laser Surgical Instrument. It is intended for use in general and plastic surgery and in dermatology, specifically for procedures requiring the coagulation of soft tissue.
Summary parsed at:2026-06-01 05:23:23 UTC
Predicate devices
3LASEMD Laser System
JOULE SYSTEM
Medical diode laser systems (CHARISMA, REGAL)
K251699 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251699 as a predicate