# K152856: Helios III

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Jun 2, 2016 after 247 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: 18 generations back to K943450 (1995). 270 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133254: Revlite Q-Switched ND:Yag Laser System, Cynosure, Inc. (2014) Summary page 4.
- K083203: Helios II Q-Switched ND:Yag Laser System, Laseroptek Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K212663: Helios IV 785 (2022), 3 descendants of its own
- K230373: HELIOS 785 Pico (2023), 2 descendants of its own
- K243780: HELIOS 785 Pico (1754V2) (2025), 0 descendants of its own
- K242206: Activo (2024), 0 descendants of its own
- K240752: Deka Toro (2024), 0 descendants of its own

## Indications for use
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 nm) nevus of ota (1064 nm)

Source page: https://510kreport.com/device/K152856
Methodology: https://510kreport.com/methodology