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510(k) K801591

FIBER OPTIC ILLUMINATOR by Lares Manufacturing Co., Inc. — Product Code EAY

K801591 is an FDA 510(k) premarket notification submitted by Lares Manufacturing Co., Inc. for the device "FIBER OPTIC ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Lares Manufacturing Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
July 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Fiber Optic, Dental
Device Class
Class I
Regulation Number
872.4620
Review Panel
DE
Submission Type

Other clearances by Lares Manufacturing Co., Inc.

  • K831351 — PERMALUX VISIBLE CURE COMPOSITE RESTOR (November 14, 1983)
  • K801535 — LARES HANDPIECE OIL (December 16, 1980)
  • K801592 — FIBER OPTIC HOSE (July 21, 1980)
  • K801534 — LARES AIR PRESSURE GAUGE (July 14, 1980)
  • K780038 — DENTAL HANDPIECE (January 20, 1978)

Other clearances for product code EAY

  • K953191 — MODEL A15-101 (September 5, 1995)
  • K953192 — MODEL A15-103 (September 5, 1995)
  • K935718 — JEDENTAL VLC DENTAL CURING LIGHT (January 26, 1994)
  • K871816 — STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM (August 3, 1987)
  • K831976 — POWER OPTIC (August 12, 1983)
  • K831824 — DENTAL ELECTRONIC/S.B.R TRADING BU HAND (August 11, 1983)
  • K820907 — DENTISCOPE (May 5, 1982)
  • K812605 — FIBER OPTIC LIGHT SOURCE I (October 2, 1981)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802716 — DEN-MAT FIBER OPTIC HALOGEN LIGHT (November 12, 1980)

FDA data resources