OPTILITE IX LASER SURGERY ACCESSORIES— 510(k) K992866

Clearance details

Applicant

Convergent Laser Technologies

Product code

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

1999-08-25

Decision date

1999-11-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakland, CA, US

• K261562 — Diode Laser Therapy System2026-09-10
• K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)2026-09-10
• K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
• K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
• K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

• K211517 — Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories2021-11-09

Death

33

Injury

3,045

Malfunction

12,903

Other

25

Total

16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0162-2020 — OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036Class III·Terminated·Xintec Corp·20171029
• Z-2866-2017 — OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.Class II·Terminated·Xintec Corp·20170623

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992866.