# K992866: Optilite IX Laser Surgery Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Laser Technologies
- Decided: Nov 18, 1999 after 85 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
118 later devices descend from it; 2 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own

## Recalls of this device
- Oct 29, 2017 · Class III · Z-0162-2020: It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugg
- Jun 23, 2017 · Class II · Z-2866-2017: It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The prelimina

## Indications for use
The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have been cleared.

Source page: https://510kreport.com/device/K992866
Methodology: https://510kreport.com/methodology