# K083203: Helios II Q-Switched ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Apr 28, 2009 after 180 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: 3 generations back to K971207 (1998). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053139: Fotona QX ND:Yag/KTP Laser System, Fotona D.D. (2006) Summary page 2.
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001)
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002)

## Most influential descendants
- K152856: Helios III (2016), 5 descendants of its own
- 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

## Indications for use
Incision, excision, ablation, vaporization of soft tissue for general dermatology. Removal or lightening of unwanted hair with or without adjuvant preparation. Tattoo Removal * dark ink: blue and black * light ink: red * light ink: sky blue * light ink: green Treatment of Vascular Lesions: * port wine birthmarks * telangiectasias * spider angioma * cherry angioma * spider nevi Treatment of Pigmented Lesions: * cafAau-lait birthmarks * solar lentiginos * senile lentiginos * backer's nevi * freckles * nevus spilus * nevus of ota

Source page: https://510kreport.com/device/K083203
Methodology: https://510kreport.com/methodology