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Directed Energy, Inc.

FDA 510(k) & PMA Approved Devices — 39 products

Total Devices39
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K904930 SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CHGEX1991-03-21 View
510(k) K894241 MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENTGEX1990-06-18 View
510(k) K883738 CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.GEX1988-11-15 View
510(k) K882926 MODEL AU-1 ACCESSORY UNITGEX1988-09-09 View
510(k) K880216 MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.GEX1988-03-04 View
510(k) K873331 ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURGHRX1988-02-17 View
510(k) K872709 MODEL 20-C, RL-20A/U, OB-10A/UHHR1988-02-02 View
510(k) K870841 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNHHR1988-02-02 View
510(k) K872711 MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERYGEX1987-09-28 View
510(k) K872710 MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATEWG1987-09-24 View
510(k) K870840 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACHEWG1987-06-12 View
510(k) K870837 MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USEGEX1987-05-26 View
510(k) K870970 MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENTGEX1987-05-26 View
510(k) K870971 MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENTGEX1987-05-26 View
510(k) K870838 MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USEGEX1987-05-26 View
510(k) K870839 MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMICHQF1987-05-22 View
510(k) K871032 MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.LNK1987-05-18 View
510(k) K871029 MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.LNK1987-05-18 View
510(k) K871030 MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.LNK1987-05-15 View
510(k) K871031 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRHLNK1987-05-15 View
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