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510(k) K913135

LM-300TWIN by Leisegang Medical, Inc. — Product Code FSW

K913135 is an FDA 510(k) premarket notification submitted by Leisegang Medical, Inc. for the device "LM-300TWIN". The FDA issued a decision of Substantially Equivalent on September 18, 1991. The device falls under product code FSW (Light, Surgical, Endoscopic), a Class II device regulated under 21 CFR 878.4580. Leisegang Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1991
Date Received
July 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Endoscopic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Leisegang Medical, Inc.

  • K990043 — SMOOTHLASE ALEXANDRITE LASER SYSTEM (February 11, 1999)
  • K940094 — COLPOSCOPES AND ACCESSORIES (April 25, 1995)
  • K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (July 2, 1993)
  • K920217 — MAX-E-VAC (July 23, 1992)
  • K914201 — LM- LAP 10 HIGH FLOW INSUFFLATOR (January 9, 1992)
  • K912789 — LM-100/200LOW FLOW INSUFFLATOR (September 20, 1991)
  • K911212 — LM-150HT LIGHT SOURCE (May 23, 1991)
  • K902313 — LM-1Z ZOOM SCOPE (September 4, 1990)
  • K854767 — LM 1000 (January 24, 1986)

Other clearances for product code FSW

  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)
  • K943342 — MEDICAM XENON LIGHT SOURCE (October 17, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)
  • K894319 — MEDICAL DYNAMICS LIGHT SOURCE (October 3, 1989)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)

FDA data resources