Ceram Optec, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15, CERALAS D10 810NM LASER, MODEL CERALAS D10-60, CERALAS D10 810NM DIODE LASER
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ceram Optec, Inc. General & Plastic Surgery ✕
27 devices
Cleared
Oct 02, 2000
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
General & Plastic Surgery
66d
Cleared
Aug 04, 2000
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
General & Plastic Surgery
36d
Cleared
Feb 01, 2000
CERALAS D10 810NM DIODE LASER
General & Plastic Surgery
81d
Cleared
Feb 01, 2000
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
General & Plastic Surgery
77d
Cleared
Oct 14, 1999
CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15
General & Plastic Surgery
37d
Cleared
Sep 01, 1999
CERALAS D10 810NM DIODE LASER
General & Plastic Surgery
14d
Cleared
Jun 24, 1999
CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
General & Plastic Surgery
21d
Cleared
Feb 03, 1999
CERALAS DIODE LASER SYSTEM (MODEL H)
General & Plastic Surgery
90d
Cleared
Oct 21, 1998
CERALAS D LASER SYSTEM, MODEL # CERALAS D15
General & Plastic Surgery
50d
Cleared
Jul 29, 1998
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES
General & Plastic Surgery
177d
Cleared
Jun 25, 1998
CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3
General & Plastic Surgery
90d
Cleared
Jun 02, 1998
REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM
General & Plastic Surgery
90d