Directed Energy, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K904930SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CHMarch 21, 1991
K894241MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENTJune 18, 1990
K883738CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.November 15, 1988
K882926MODEL AU-1 ACCESSORY UNITSeptember 9, 1988
K880216MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.March 4, 1988
K873331ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURGFebruary 17, 1988
K872709MODEL 20-C, RL-20A/U, OB-10A/UFebruary 2, 1988
K870841MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNFebruary 2, 1988
K872711MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERYSeptember 28, 1987
K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATSeptember 24, 1987
K870840MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACHJune 12, 1987
K870837MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USEMay 26, 1987
K870971MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENTMay 26, 1987
K870970MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENTMay 26, 1987
K870838MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USEMay 26, 1987
K870839MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMICMay 22, 1987
K871029MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.May 18, 1987
K871032MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.May 18, 1987
K87103110-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRHMay 15, 1987
K871030MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.May 15, 1987