# K983868: Opmi Twiner Surgical Microscope

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Jan 29, 1999 after 88 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 K900077 (1990). 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)
- K900077: Sharplan 1041 Sealed-Off CO2 Surgical Laser System, Sharplan Lasers, Inc. (1990) Summary page 1.
- K933841: Centauri, Premier Laser Systems, Inc. (1997) Summary page 1.

## Indications for use
This device will be used in the same manner as all; (2) surgical microscopes are used and (b) as all lasers are used in ENT and general surgery not requiring photocoagulation. The device is primarily intended to allow surgeons to perform tissue ablation with minimal peripheral thermal effects. More specifically, the device can be used for: general surgery which does not require photocoagulation; and in ENT applications, including microsurgery in the middle ear, stapedoplasty, for preparation of sites for osteosynthesis, microsurgery on ossicles, tympanic membrane, ablative surgery on soft tissues (for example: ligament severance of the stapes muscle), and removal of exostosis. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

Source page: https://510kreport.com/device/K983868
Methodology: https://510kreport.com/methodology