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510(k) K862150

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) by Directed Energy, Inc. — Product Code EWG

K862150 is an FDA 510(k) premarket notification submitted by Directed Energy, Inc. for the device "MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)". The FDA issued a decision of SN on September 4, 1986. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Directed Energy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 4, 1986
Date Received
June 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ent Microsurgical Carbon-Dioxide
Device Class
Class II
Regulation Number
874.4500
Review Panel
EN
Submission Type

Other clearances by Directed Energy, Inc.

  • K904930 — SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH (March 21, 1991)
  • K894241 — MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT (June 18, 1990)
  • K883738 — CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. (November 15, 1988)
  • K882926 — MODEL AU-1 ACCESSORY UNIT (September 9, 1988)
  • K880216 — MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. (March 4, 1988)
  • K873331 — ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG (February 17, 1988)
  • K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (February 2, 1988)
  • K872709 — MODEL 20-C, RL-20A/U, OB-10A/U (February 2, 1988)
  • K872711 — MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY (September 28, 1987)
  • K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (September 24, 1987)

Other clearances for product code EWG

  • K924652 — BENSON CCA100 (April 9, 1993)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (September 24, 1987)
  • K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (June 12, 1987)
  • K864975 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) (February 25, 1987)
  • K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (January 9, 1987)
  • K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (January 9, 1987)

FDA data resources