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510(k) K911212

LM-150HT LIGHT SOURCE by Leisegang Medical, Inc. — Product Code ESI

K911212 is an FDA 510(k) premarket notification submitted by Leisegang Medical, Inc. for the device "LM-150HT LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on May 23, 1991. The device falls under product code ESI (Polymer, Natural-Absorbable Gelatin Material), a Class III device. Leisegang Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1991
Date Received
March 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Natural-Absorbable Gelatin Material
Device Class
Class III
Regulation Number
Review Panel
EN
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)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K902313 — LM-1Z ZOOM SCOPE (September 4, 1990)
  • K854767 — LM 1000 (January 24, 1986)

Other clearances for product code ESI

  • K954401 — GASTROTEC (April 25, 1996)

FDA data resources