LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES— 510(k) K011703

Name: FDA 510(k) clearance K011703
Creator: U.S. Food and Drug Administration
Published: 2001-08-29

Substantially Equivalent

Lumenis

FDA 510(k) clearance K011703 for LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES, Substantially Equivalent on 2001-08-29. Applicant: Lumenis. Device class: 2.

Clearance details

Applicant: Lumenis
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2001-06-01
Decision date: 2001-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

view all

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

More clearances from Lumenis

view all

K100415 — ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM2010-04-21
K030527 — LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS2003-05-20
K020591 — BCLEAR2002-05-16
K011197 — DERMACLEAR UV-B PHOTOTHERAPY SYSTEM2001-12-14

Adverse events under product code GEX

product code GEX

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.