K837030Substantially Equivalent

Model Ml-4000 Ophthalmic Laser with Fiber Optic Delivery System

Name: K837030 Model Ml-4000 Ophthalmic Laser with Fiber Optic Delivery System
Creator: Meditec, Inc.
Published: 1983-01-24
License: https://open.fda.gov/license/

Meditec Co., Ltd., Englewood CO / Traditional, Substantially Equivalent

FDA source

K837030 is the FDA 510(k) clearance record for MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM, cleared for Meditec, Inc. on 1983-01-24. FDA records list 8 510(k) clearances for Meditec, Inc., from 1983-01-24 to 2004-07-15. As of 2026-09-10, FDA records show no recalls naming K837030.

Clearance record

Decision date: 1983-01-24
Received: 1982-12-20 (35 days to decision)
Review panel: Unknown
Applicant: Meditec, Inc. 9485 E. Orchard Dr., Englewood CO
Third party review: No