FDA LASIK Device Requirements Guide

Assurentry Team · February 2026

LASIK Device Classification

LASIK (laser-assisted in situ keratomileusis) devices are Class III medical devices requiring Premarket Approval (PMA) or a PMA supplement. The laser system and associated software are subject to FDA clearance or approval before commercial distribution.

Premarket Requirements

Manufacturers must demonstrate safety and effectiveness through clinical data and engineering testing. PMA submissions include device description, manufacturing information, nonclinical and clinical studies, and labeling. Substantial equivalence through 510(k) may apply to certain modifications.

Quality Systems and cGMP

LASIK device manufacturers must comply with Quality System Regulation (QSR) under 21 CFR Part 820. With QMSR alignment, see QMSR vs. QSR for 2026 updates. Design controls, validation, and risk management are critical.

Registration, Listing, and UDI

Establishments must register and list LASIK devices with FDA. Unique Device Identification (UDI) applies. See UDI compliance for implementation guidance.

Postmarket Obligations

MDR reporting, recalls, and corrections apply. Maintain design history files, risk documentation, and complaint handling systems. Surgical facilities using LASIK devices have separate obligations.