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510(k) K894557

LIGHTSCOPE SET by Optik — Product Code HRW

K894557 is an FDA 510(k) premarket notification submitted by Optik for the device "LIGHTSCOPE SET". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250. Optik has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Nonpowered
Device Class
Class I
Regulation Number
888.1250
Review Panel
NE
Submission Type

Other clearances by Optik

  • K933776 — OPTIK LAPAROSCOPE (March 16, 1994)
  • K926166 — COAST VIDEO ENDOSCOPIC IMAGING SYSTEM (June 1, 1993)
  • K896404 — TITAMED ANTWERP SYSTEM (April 16, 1990)
  • K896589 — MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (December 27, 1989)
  • K894558 — MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET (August 7, 1989)

Other clearances for product code HRW

  • K971407 — JTECH COMMANDER AND ALGOMETER (April 20, 1998)
  • K970870 — DIGIT-GRIP WITH LCD (DGR002) (May 2, 1997)
  • K861396 — HANDHELD DYNAMOMETER, MODEL #160 AND #111 (May 2, 1986)
  • K821631 — PINCH GAUGE, 0-301 LBS. (June 11, 1982)
  • K812343 — PINCH METER (September 11, 1981)
  • K801719 — BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG (August 4, 1980)
  • K791021 — MUSCLE TESTING GUN (June 15, 1979)
  • K790302 — PRESSURE MONITOR, MODEL 212 (March 21, 1979)
  • K772415 — DYNAMETER 50 LB. (January 5, 1978)
  • K772413 — PINCH GUAGE (January 5, 1978)

FDA data resources