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The Botticelli (Model: Athena)

Bellamia Technologies, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Bellamia Technologies, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3
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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

3

K251699 references 3 predicate/reference devices

Cited as predicate

0

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