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WAVELIGHT FS200 LASER SYSTEM

K141476 Class II Traditional
Decision Date
2014-09-30
Sponsor / Applicant
Alcon Research, Ltd. Dba Alcon Laboratories, Inc.

Technical Specification

510(k) Submission ID K141476
Product Code OOE
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.4390
Decision Date 2014-09-30
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

WAVELIGHT FS200 LASER SYSTEM received FDA 510(k) clearance under submission number K141476, sponsored by Alcon Research, Ltd. Dba Alcon Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2014-09-30.

Classification & Regulation

This clearance is catalogued under FDA product code OOE and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.