510(k) K862518

BAUSCH & LOMB VERTOMETER V-5 by Bausch & Lomb, Inc. — Product Code HLM

K862518 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BAUSCH & LOMB VERTOMETER V-5". The FDA issued a decision of Substantially Equivalent on August 11, 1986. The device falls under product code HLM (Instrument, Measuring, Lens, Ac-Powered), a Class I device regulated under 21 CFR 886.1425. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1986
Date Received
July 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Lens, Ac-Powered
Device Class
Class I
Regulation Number
886.1425
Review Panel
OP
Submission Type