An ambulatory surgical facility is a distinct entity whose primary purpose is to furnish same day outpatient surgical services to patients. A facility that offers LASIK as one of its ophthalmic surgical procedures may also provide non-ophthalmic surgical services. Consider all surgical services provided by a facility when determining whether a facility meets the MDR definition of an ambulatory surgical facility and is therefore subject to the user facility obligations under MDR.
Source : USFDA