>O ar kas domėjosi ką konkrečiai tie "sertifikatai" nusako?

  Kurie "kokybės" -- taip ir yra, nieko rimtesnio nenusako.
  Su paskutiniu dar paprasčiau:

"In order to be eligible for 510(k) clearance, the new device must exhibit
roughly the same safety and effectiveness characteristics as the “predicate”
device to which the new one is being compared. An example of technological
advancement under this process was marketing clearance of lasers for “cutting
or ablation” of tissues when compared with a heated wire cautery device."
http://www.devicewatch.org/reg/510k.shtml

  Pagal duotą registracijos kodą galima rasti sertifikuojančios įstaigos
išvadas, kurios svarbiausio (kas ten per predicate device) taip ir nepasako.
Konkrečiausios galutiniam juzeriui bus šitos užuominos:

Regulation Name: Lamp, non-heating, for adjunctive use in pain therapy

Indications for Use: The Bioptron Pro and Bioptron Compact III Light Therapy
Systems is indicated for adjunctive use in providing temporary relief of
minor chronic neck and shoulder pain of musculoskeletal origin.

-- 
  saimhe