DeviceClearance

Product code FSY— General, Plastic Surgery

CHROMOPHARE

Classification name
Light, Surgical, Ceiling Mounted
Device class
Class 2
Regulation
21 CFR 878.4580
Advisory panel
General, Plastic Surgery
Total cleared
74
First cleared
Most recent

Market context for product code FSY

FDA has cleared 74 devices under product code FSY between 1977 and 2014, filed by 43 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

last 15 years

Top applicants under product code FSY

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FSY

Data sourced from openFDA. This site is unofficial and independent of the FDA.