# K212663: Helios IV 785

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Jun 9, 2022 after 290 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: 25 generations back to K943450 (1995). 288 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152856: Helios III, Laseroptek Co., Ltd. (2016) Summary page 5.
- K170597: PicoWay Laser System, Syneron Candela Corporation (2017) Summary page 5.

## Most influential descendants
- K230373: HELIOS 785 Pico (2023), 2 descendants of its own
- K243780: HELIOS 785 Pico (1754V2) (2025), 0 descendants of its own
- K240752: Deka Toro (2024), 0 descendants of its own

## Indications for use
[Indication for use of Q-switched Nd:YAG Laser] - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) - Tattoo Removal (1064nm, 532nm) * dark ink : blue and black (1064nm) » light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) * port wine birthmarks » telangiectaias * spider angioma * cherry angioma * spider nevi - Treatment of Pigmented Lesions (1064nm, 532nm) » café-au-lait birthmarks (532nm) * solar lentiginos (532nm) » senile lentiginos (532nm) * becker's nevi (532nm) * freckles (532nm) * nevus spilus (532nm) * nevus of ota (1064nm) [Indication 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/K212663
Methodology: https://510kreport.com/methodology