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510(k) K790526

LIO-714 OPACITYMETER by Laser Industries , Ltd. — Product Code HJL

K790526 is an FDA 510(k) premarket notification submitted by Laser Industries , Ltd. for the device "LIO-714 OPACITYMETER". The FDA issued a decision of Substantially Equivalent on November 16, 1979. The device falls under product code HJL (Lens, Condensing, Diagnostic), a Class I device regulated under 21 CFR 886.1380. Laser Industries , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1979
Date Received
March 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Condensing, Diagnostic
Device Class
Class I
Regulation Number
886.1380
Review Panel
OP
Submission Type

Other clearances by Laser Industries , Ltd.

  • K933362 — SHARPLAN CO2 SURGICAL LASER (April 7, 1994)
  • K894765 — SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 (September 28, 1989)
  • K850633 — SHARPLAN MODEL 1060 CO/2 SURGICAL LASER (August 7, 1985)
  • K850628 — SHARPLAN 1040 CO/2 SURGICAL LASER (August 7, 1985)
  • K842997 — LASER RECTOSCOPE SET 784 (August 27, 1984)
  • K832550 — SHARPLAN #734 LASER SURGICAL UNIT (April 25, 1984)
  • K832551 — SHARPLAN #745 LASER SURG. UNIT (April 23, 1984)
  • K832316 — OPHTHALMIC ARGON LASER #700A (January 30, 1984)
  • K837573 — SHARPLAN LASER POSITIONING SYSTEM (June 28, 1983)
  • K837342 — SHARPLAN 721 CO2 SURGICAL LASER (May 18, 1983)

FDA data resources