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510(k) K802770

FIBER OPTIC HEADLIGHT #60-0766766 by Aspen Laboratories, Inc. — Product Code FCT

K802770 is an FDA 510(k) premarket notification submitted by Aspen Laboratories, Inc. for the device "FIBER OPTIC HEADLIGHT #60-0766766". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code FCT (Headlight, Fiberoptic Focusing), a Class II device regulated under 21 CFR 886.4335. Aspen Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlight, Fiberoptic Focusing
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type

Other clearances by Aspen Laboratories, Inc.

  • K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
  • K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
  • K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT (July 11, 1996)
  • K960296 — 4000 ETM (February 20, 1996)
  • K953081 — BEAMER PLUS (October 30, 1995)
  • K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
  • K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
  • K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

Other clearances for product code FCT

  • K960767 — LIGHT COMMANDER (August 26, 1996)
  • K924198 — MODIFIED SITE FIBER OPTIC MODULE (November 23, 1992)
  • K883480 — MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (August 24, 1988)
  • K802769 — FIBER OPTIC HEADLIGHT #60-0765 (December 11, 1980)
  • K780433 — FIBER OPTIC ADJUSTABLE HEADLIGHT (June 13, 1978)

FDA data resources