COAGULATOR, MODEL 40 AARGON— 510(k) K782106

Name: FDA 510(k) clearance K782106
Creator: U.S. Food and Drug Administration
Published: 1979-02-08

Substantially Equivalent

Lasertek OY

FDA 510(k) clearance K782106 for COAGULATOR, MODEL 40 AARGON, Substantially Equivalent on 1979-02-08. Applicant: Lasertek OY. Device class: 2.

Clearance details

Applicant: Lasertek OY
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 1978-12-13
Decision date: 1979-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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 Lasertek OY

view all

K832089 — MODEL 150K LASER COAGULATOR1984-01-30
K828326 — UNKNOWN1983-03-04
K781965 — LASER COAGULATOR, MODEL 41AK1979-02-08

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.