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510(k) K870841

MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN by Directed Energy, Inc. — Product Code HHR

K870841 is an FDA 510(k) premarket notification submitted by Directed Energy, Inc. for the device "MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Directed Energy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
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)
  • 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)
  • K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (June 12, 1987)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)

FDA data resources