Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse— 510(k) K231011

Name: FDA 510(k) clearance K231011
Creator: U.S. Food and Drug Administration
Published: 2023-09-12

Substantially Equivalent

Meridian AG

FDA 510(k) clearance K231011 for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse, Substantially Equivalent on 2023-09-12. Applicant: Meridian AG. Device class: 2.

Clearance details

Applicant: Meridian AG
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2023-04-10
Decision date: 2023-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thun, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQF

view all

K252979 — Voyager DSLT (430840610)2026-04-07
K251507 — INTEGRE LIO2026-02-06
K251772 — Navilas Laser System 577sl (156691)2025-10-29
K243014 — EyeQ nanoECP2025-06-18
K240615 — Leos Laser and Endoscopy System2025-04-03

More clearances from Meridian AG

view all

K232417 — MR Q; MR Q SUPINE; MR Q SLT2024-01-25
K160677 — MICRORUPTOR 62017-05-19
K113390 — LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)2012-02-14
K072823 — MERILAS 532A2007-12-14
K023045 — MICRORUPTER V2002-09-26

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.