FDA POSTS INFORMATION ON TWO DEVICES

The FDA Aug. 25 posted to its website information for one recently approved device and a correction on its wording for use indications for another product.

The agency published summary information for the MEL 80 excimer laser system, which was approved Aug. 11. The device is manufactured by Carl Zeiss Meditec and is used in LASIK treatments to reduce or eliminate myopia.

The FDA also posted updated information on the Visian implantable collamer lens (ICL), including a Jan. 4 letter offering a correction on its wording for the indications for use of the product. The device was approved Dec. 22, 2005, and is manufactured by STAAR Surgical.

The approval letter for the MEL 80 can be viewed at www.fda.gov/cdrh/pdf6/p060004a.pdf (http://www.fda.gov/cdrh/pdf6/p060004a.pdf).

The correction letter for the Visian ICL can be viewed at www.fda.gov/cdrh/pdf3/p030016a.pdf (http://www.fda.gov/cdrh/pdf3/p030016a.pdf).