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510(k) K871031

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH by Directed Energy, Inc. — Product Code LNK

K871031 is an FDA 510(k) premarket notification submitted by Directed Energy, Inc. for the device "10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH". The FDA issued a decision of Substantially Equivalent on May 15, 1987. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Directed Energy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1987
Date Received
March 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
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 LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)

FDA data resources