SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA +48 more— 510(k) K243121

Clearance details

Device name as filed

SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;

Applicant

Jiangxi Medex Technology Co., Ltd.

Product code

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2024-09-30

Decision date

2024-12-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jiangxi, CN

• K241973 — SmartIPL_NI System2026-09-19
• K252723 — Dynamis Pro Family2026-09-19
• K261047 — Dental Diode Laser Device (Laser-Pen)2026-09-18
• K261673 — LED Therapy Device (QLXY-01)2026-09-17
• K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)2026-09-17

• K243141 — Diode Laser System (5 models)2024-12-26

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 →