510(k) K912134

TBD, LENS MEASURING DEVICE by Alcon Laboratories — Product Code HRJ

K912134 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "TBD, LENS MEASURING DEVICE". The FDA issued a decision of Substantially Equivalent on July 25, 1991. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Alcon Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1991
Date Received
May 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Instrument, Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.4855
Review Panel
OP
Submission Type