510(k) K100954
K100954 is an FDA 510(k) premarket notification submitted by Apeliotus Vision Science, Inc. for the device "ADAPT, MODEL AX-03SN". The FDA issued a decision of Substantially Equivalent on February 25, 2011. The device falls under product code OUM (Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation), a Class I device regulated under 21 CFR 886.1050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2011
- Date Received
- April 7, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
- Device Class
- Class I
- Regulation Number
- 886.1050
- Review Panel
- OP
- Submission Type
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.