Product code HOT— Ophthalmic
SPECTACLE, MAGNIFYING
- Classification name
- Aid, Vision Image Intensification
- Device class
- Class 1
- Regulation
- 21 CFR 886.5910
- Advisory panel
- Ophthalmic
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code HOT
FDA has cleared devices under product code HOT between 1986 and 1988, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1988
- 1986
Top applicants under product code HOT
Recent clearances under product code HOT
Data sourced from openFDA. This site is unofficial and independent of the FDA.