# K120932: Opelaser Pro II and the Opelaser Lite II

- Pathway: 510(k) (Traditional)
- Applicant: The Yoshida Dental Mfg. Co., Ltd.
- Decided: Dec 7, 2012 after 254 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: 6 generations back to K936109 (1994). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031440: Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser, Cynosure, Inc. (2003) Summary page 1.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.

## Indications for use
The Opelaser Family is C02 Medical Laser Systems (and the delivery system that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

Source page: https://510kreport.com/device/K120932
Methodology: https://510kreport.com/methodology