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510(k) K854470

PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI by Minnesota Laser Corp. — Product Code HHR

K854470 is an FDA 510(k) premarket notification submitted by Minnesota Laser Corp. for the device "PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI". The FDA issued a decision of Substantially Equivalent on February 7, 1986. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Minnesota Laser Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1986
Date Received
November 6, 1985
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 Minnesota Laser Corp.

  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (March 4, 1988)
  • K854473 — PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854468 — PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854471 — PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T (February 13, 1986)
  • K854469 — PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854472 — PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K852694 — PORTALASE 200 CARBON SURGICAL LASER SYSTEM (September 30, 1985)
  • K852696 — FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY (September 19, 1985)

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