Product code FCT— Ophthalmic

FDA has cleared 6 devices under product code FCT between 1978 and 1996, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19961 clearance
• 19921 clearance
• 19881 clearance
• 19802 clearances
• 19781 clearance

• Aspen Laboratories, Inc.2 clearances
• Site Microsurgical Systems, Inc.1 clearance
• Scieran Technologies, Inc.1 clearance
• Chiron Vision Corp.1 clearance
• Cameron-Miller, Inc.1 clearance

• K960767 — LIGHT COMMANDERScieran Technologies, Inc.·1996-08-26
• K924198 — MODIFIED SITE FIBER OPTIC MODULEChiron Vision Corp.·1992-11-23
• K883480 — MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USESite Microsurgical Systems, Inc.·1988-08-24
• K802769 — FIBER OPTIC HEADLIGHT #60-0765Aspen Laboratories, Inc.·1980-12-11
• K802770 — FIBER OPTIC HEADLIGHT #60-0766766Aspen Laboratories, Inc.·1980-12-11
• K780433 — FIBER OPTIC ADJUSTABLE HEADLIGHTCameron-Miller, Inc.·1978-06-13