Apply one 510(k) for both surgical and therapy laser?

Can we apply one 510(k) to cover both surgical and therapy laser. We got one 510(k) for one surgical laser and another 510(k) for another therapy laser, both of them have different intended use.

In theory, yes. You just have to create a 510(k) documentation package that proves your single device is safe and effective for multiple disparate intended uses. The more complicated the intended use(s), the harder that task, of course.

Let give more clarifications:


We got one 510(k) for one surgical laser named A and another 510(k) for another therapy laser named B, both of them have different intended use.

If we want to design a third device which combines the functions of A and B, and use a switch to change the device between A and B with different indication of use.

Can we apply one 510(k) to cover this new device with both surgical and therapy laser function?

If yes, how can not find the predicate device (no predicate device has both different functions and indication of uses)?

luloo117117 said:

We got one 510(k) for one surgical laser named A and another 510(k) for another therapy laser named B, both of them have different intended use.

If we want to design a third device which combines the functions of A and B, and use a switch to change the device between A and B with different indication of use.

Can we apply one 510(k) to cover this new device with both surgical and therapy laser function?

Click to expand...

Yes, as above.

If yes, how can not find the predicate device (no predicate device has both different functions and indication of uses)?

Click to expand...

Yes, the more complicated and novel the product, the harder it is to follow the 510(k) path successfully.

If a product is truly novel, the FDA may require a PMA instead of a 510(k).

In theory, it may be possible to identify separate predicate devices for each of multiple intended uses. This however will require some fancy footwork in regard to 510(k) writing to address all of the issues for every possible scenario, and all of the possible objections.

Combining multiple dissimilar functions, in particular, may make for a highly complex risk analysis.

luloo117117 said:

If yes, how can not find the predicate device (no predicate device has both different functions and indication of uses)?

Click to expand...

Take a look at this submission:

http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081704.pdf

or this:

http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060448.pdfhttp://www.accessdata.fda.gov/cdrh_docs/pdf6/K060448.pdf

It can give you some ideas how to present the info (like selecting predicate devices, intended use and indications for use, family of products, product code and subsequent code, etc.)

Thank you Yana,

I took a look at the 510(k) you attached are all GEX.

Our product A is ILY according to the approved FDA letter, and product B is GEX. I really not sure if we can find any predicate device for the "combination" product (one product has the common functions product A and B have).

K061614 and K080102 product codes are "ILY,GEX". But their indication of use looks like only the ILY (heating lamp), not GEX (general surgical). I am confused.

surely you can add if both are same class of medical device.

with kind regards

Sanjay Lingot