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510(k) K870839

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC by Directed Energy, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1987
Date Received
February 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
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)

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