← FDA Medical Device Classifications
Loupe, Binocular, Low Power
HJH · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.5120
Classification
- FDA Product Code
HJH- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 886.5120
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 44
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown