← FDA Medical Device Classifications
Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
OUM · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1050
Classification
- FDA Product Code
OUM- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 886.1050
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown