Product code HJE— General, Plastic Surgery
EXAMINER 10
- Classification name
- Lamp, Fluorescein, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code HJE
FDA has cleared devices under product code HJE between 1978 and 1992, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1992
- 1980
- 1978
Top applicants under product code HJE
Recent clearances under product code HJE
Data sourced from openFDA. This site is unofficial and independent of the FDA.