510(k) K023249
K023249 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2002. The device falls under product code NCF (Aberrometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2002
- Date Received
- September 30, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aberrometer, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1760
- Review Panel
- OP
- Submission Type