ORBSCAN— 510(k) K984443

Substantially Equivalent

Technolas Perfect Vision GmbH

FDA 510(k) clearance K984443 for ORBSCAN, Substantially Equivalent on 1999-03-05. Applicant: Technolas Perfect Vision GmbH. Device class: 2.

Clearance details

Applicant: Technolas Perfect Vision GmbH
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 1998-12-14
Decision date: 1999-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXK

K251848 — Pentacam® Cornea OCT2026-03-13
K252348 — Tomey Optical Biometer OA-2000 (OA-2000)2025-12-18
K223700 — BOSS2024-08-16
K222933 — MYAH2023-06-29
K211868 — MYAH2022-03-01

More clearances from Technolas Perfect Vision GmbH

K200724 — VICTUS Femtosecond Laser Platform2020-09-01
K171014 — VICTUS Femtosecond Laser Platform2017-10-19
K151161 — VICTUS Femtosecond Laser Platform2015-06-24
K141379 — VICTUS FEMTOSECOND LASER PLATFORM2015-01-16
K140615 — VICTUS FEMTOSECOND LASER PLATFORM2014-07-15

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