Product code HJN— Ophthalmic
LULMITEX NEONATAL TRANSILLUMINATOR
- Classification name
- Transilluminator, Battery-Powered
- Device class
- Class 1
- Regulation
- 21 CFR 886.1945
- Advisory panel
- Ophthalmic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code HJN
FDA has cleared devices under product code HJN between 1990 and 1994, filed by 3 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
- 1994
- 1991
- 1990
Top applicants under product code HJN
Recent clearances under product code HJN
Data sourced from openFDA. This site is unofficial and independent of the FDA.