510(k) K912134
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