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510(k) K880591

LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE by Laser Peripherals, LLC — Product Code HHR

K880591 is an FDA 510(k) premarket notification submitted by Laser Peripherals, LLC for the device "LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Laser Peripherals, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1988
Date Received
February 11, 1988
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 Laser Peripherals, LLC

  • K170366 — Laser Peripherals, LLC Family of Bare Laser Fibers (June 8, 2017)
  • K030959 — BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-10 (April 25, 2003)
  • K011207 — LASER PERIPHERALS REUSABLE HOLMIUM FIBER (July 24, 2001)
  • K992083 — SCATTERFREE LATERAL EMITTING FIBER (July 12, 1999)
  • K974229 — LS-905 FIBERCHOICE ADAPTER SYSTEM (February 10, 1998)
  • K972272 — LASER PERIPHERALS HOLMIUM BARE FIBERS (July 29, 1997)
  • K961516 — LASER PERIPHERALS INC. BARE FIBER (June 27, 1996)
  • K961079 — LASER PERIPHERALS INC. SCATTERFREE FIBER (May 22, 1996)
  • K901786 — LASEGUIDE CAT # CLF-600D & CLF-1000D (June 27, 1990)
  • K880592 — LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (April 25, 1988)

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)
  • 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)
  • K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (February 2, 1988)

FDA data resources