Q I understood that SMILE is good so why has FDA not approved it?

FDA takes a long time not just for due diligence but also due to their high fees. Since the best lasers in the world of optics are from Germany, after manufacturing expensive equipment, these companies need to recover first, get the CE approval from Europe, and then need to get millions of dollars to fund the US FDA exercise. Hence, the lasers which we use in Europe and Asia are far ahead of time than that found in USA.

Just to let you know, this laser- Zeiss is already a popular Femtosecond laser in the USA, but needs a FDA nod for its SMILE profile. Same laser, same laser beam, different application.

Many hence take the advantage of India as it is not just cheaper than USA but also more advanced, hence Medical tourism a booming industry.

Waiting for FDA approvals delays you receiving the treatment, but yes, if that is what people wish to do, they do so, as any laser eye surgery is an elective choice.

When we at Shroff Eye were the first in India to use the Wavelight Allegretto Eye Q 400 hz excimer laser for LASIK, it had not got the FDA approval. It entered US soil 4-5 years later than us, and today is one of their most popular lasers. Whereas, here in India, we moved on…maturing or evolving to now use the same company’s 500 Hz laser, which is not FDA approved as yet!

Posted in: Questions on ReLEx SmILE Procedure and Doctor experience with procedure