# K211605: Dual Switch

- Pathway: 510(k) (Special)
- Applicant: Laser Engineering, Inc.
- Decided: Sep 22, 2022 after 485 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: 1 generation back to K905676 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905676: MD CO2 Surgical Laser System/Gen. Surgery and Orth, Laser Engineering, Inc. (1991) Summary page 4.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 4.

## Indications for use
The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, incision, excision, ablation, or photocaogulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

Source page: https://510kreport.com/device/K211605
Methodology: https://510kreport.com/methodology