510(k) K931855

LIGHTWRITER by Zygo Corp. — Product Code ILQ

K931855 is an FDA 510(k) premarket notification submitted by Zygo Corp. for the device "LIGHTWRITER". The FDA issued a decision of Substantially Equivalent on May 10, 1994. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1994
Date Received
April 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type