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510(k) K881334

LIGHT COAGULATOR LC 250 by Nk-Optik GmbH — Product Code HAM

K881334 is an FDA 510(k) premarket notification submitted by Nk-Optik GmbH for the device "LIGHT COAGULATOR LC 250". The FDA issued a decision of Substantially Equivalent on November 16, 1989. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1989
Date Received
March 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K894663 — BEAMER ONE (September 15, 1989)

FDA data resources