# K253344: Bellus-Q

- Pathway: 510(k) (Traditional)
- Applicant: Speclipse, Inc.
- Decided: Nov 25, 2025 after 56 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: 29 generations back to K943450 (1995). 591 ancestors in all.
No later device cites it as a predicate yet.
0 of 592 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202172: StarWalker, Fotona D.O.O. (2020) Summary page 7.
- K241527: Pastelle Pro, Wontech Co., Ltd. (2025) Summary page 7.

## Indications for use
BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064 nm wavelength in Q-switched mode: -Removal of dark (black, blue, brown) tattoo ink -Treatment of nevus of ota -Treatment of common nevi -Removal and lightening of unwanted hair -Skin resurfacing procedures for the treatment of acne scars and wrinkles -Treatment of melasma -General dermatology indications: Incision, excision, ablation and vaporization of soft tissue 1064 nm wavelength in GENESIS mode: -Treatment of wrinkles -Treatment of mild to moderate inflammatory acne vulgaris 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): -Red, tan, purple and orange tattoo ink removal -Sky blue (light) tattoo ink removal -Green tattoo ink removal -Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus -Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi -Seborrheic Keratosis -Treatment of post-inflammatory hyperpigmentation -Skin resurfacing procedures for the treatment of acne scars and wrinkles -Removal of epidermal pigmented lesions

Source page: https://510kreport.com/device/K253344
Methodology: https://510kreport.com/methodology