# K243780: HELIOS 785 Pico (1754V2)

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Feb 7, 2025 after 60 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: 27 generations back to K943450 (1995). 574 ancestors in all.
No later device cites it as a predicate yet.
0 of 575 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230373: HELIOS 785 Pico, Laseroptek Co., Ltd. (2023) Summary page 6.
- K202288: Finebeam, SNJ Co., Ltd. (2021) Summary page 6.

## Indications for use
[Indications for use of Q-switched Nd:YAG Laser] 1064 nm (including RTP 1064 mode): - Incision, excision, ablation, vaporization of soft tissue for general dermatology - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment melasma - Treatment of Pigmented Lesions • nevus of ota - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Tattoo Removal • dark ink: black, blue and brown 532 nm: - Treatment of Vascular Lesions • port wine birthmarks • telangiectaias • spider angioma • cherry angioma • spider nevi - Treatment of Pigmented Lesions • café-au-lait birthmarks • solar lentiginos • senile lentiginos • becker’s nevi • freckles • nevus spilus • nevus of ota - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Tattoo Removal • light ink: red, sky blue, green, tan, purple, and orange [Indications for use of FR mode in Nd:YAG Laser] - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofolliculitis Barbae). The laser is indicated for 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, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles [Indications for use of Ti:Sapphire Laser] - Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 785nm: *Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously.*

Source page: https://510kreport.com/device/K243780
Methodology: https://510kreport.com/methodology