# K202288: Finebeam

- Pathway: 510(k) (Traditional)
- Applicant: SNJ Co., Ltd.
- Decided: Nov 19, 2021 after 464 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: 22 generations back to K943450 (1995). 549 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 552 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083889: Fotona QX ND:Yag/KTP Laser System Family, Fotona D.D. (2009) Summary page 5.
- K132286: Hyperion Long Pulsed ND: Yag Laser, Scarlet Rf, Inc. (2014) Summary page 6.
- K171227: StarWalker, Fotona D.O.O. (2017) Summary page 6.
- K140249: Long Pulse ND: Yag Laser System, Advanced Technology Laser Co., Ltd. (2014) Summary page 6.
- K123293: Pastelle Q-Switched ND: Yag Laser, Won Technology Co., Ltd. (2013) Summary page 6.
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,, Fotona D.D. (2009) Summary page 12.
- K132185: Family of Coolglide Aesthetic Lasers, Cutera, Inc. (2013) Summary page 12.

## Most influential descendants
- K260256: Q-Switched Nd: YAG Laser Systems (2026), 0 descendants of its own
- K243780: HELIOS 785 Pico (1754V2) (2025), 0 descendants of its own

## Indications for use
The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Q-switched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per each function for use in a variety of dermatological procedures. Each function is intended for: 1) QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function - Removal dark ink (black, blue, and brown) tattoos; - Treatment melasma, treatment nevus of Ota; - Treatment common nevi; - Removal of lightening of unwanted hair; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles 2) QSW mode with 532nm single function - Removal of light ink (red, tan, purple, and orange) tattoos; - Treatment of vascular lesions including, but not limited to port-wine stains, telangiectasias, spider angioma, cherry angioma; - Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, and nevus spilus; - Treatment of seborrheic keratosis; - Treatment of post-inflammatory hyperpigmentation; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode with 532nm single function; 3) QSW mode with 1064nm Non-Q function - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick [-VI, including tanned skin; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, Coagulation and hemostasis of soft tissue; and - Treatment of wrinkles 4) LPS mode - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins; - Coagulation and hemostasis of soft tissue; - Treatment of wrinkles and acne vulgaris

Source page: https://510kreport.com/device/K202288
Methodology: https://510kreport.com/methodology