# K182045: Lotus III Multi-Pulsed Er: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Dec 27, 2018 after 150 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: 21 generations back to K943450 (1995). 543 ancestors in all.
No later device cites it as a predicate yet.
0 of 544 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083253: Lotus II Pulsed ER: Yag Laser System, Laseroptek Co., Ltd. (2009) Summary page 5.
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid, Fotona D.D. (2010) Summary page 5.
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro, Fotona D.D. (2015) Summary page 5.

## Indications for use
The LOTUS III Multi-Pulsed 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/K182045
Methodology: https://510kreport.com/methodology