# K083253: Lotus II Pulsed ER: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: May 15, 2009 after 192 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: 4 generations back to K954013 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014057: Dermastar ER:Yag Laser System, Asclepion-Meditec AG (2002) Summary page 2.
- K042968: MCL 30 Dermablate ER:Yag Laser System, Asclepion Laser Technologies GmbH (2004) Summary page 2.

## Most influential descendants
- K182045: Lotus III Multi-Pulsed Er: Yag Laser System (2018), 0 descendants of its own

## Indications for use
The Lotus II Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Source page: https://510kreport.com/device/K083253
Methodology: https://510kreport.com/methodology