Hi TheAnalyst007 :Regarding your query about FDA approval for...

Hi TheAnalyst007 :
Regarding your query about FDA approval for marketing 2RT lasers in the USA, the following information below comes from data in the public domain.
FDA decision re 2RT says in Statement (hyperlinked in the FDA data below) : "You may, therefore. market the device, subject to the general controls provisions of the Act."

Device Classification Name	Laser, Ophthalmic
510(K) Number	K122202
Device Name	ELLEX 2RT
Applicant	Ellex Medical Pty. Ltd. 82 GILBERT ST. Adelaide, South Australia, AU 5000
Applicant Contact	Kevin Howard
Correspondent	Ellex Medical Pty. Ltd. 82 GILBERT ST. Adelaide, South Australia, AU 5000
Correspondent Contact	Kevin Howard
Regulation Number	886.4390
Classification Product Code	HQF
Date Received	07/25/2012
Decision Date	07/01/2013
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Ophthalmic
510k Review Panel	Ophthalmic
Statement	Statement
Type	Traditional
Reviewed By Third Party	No
Combination Product	No

Not to be taken as professional advice : please do your own DD