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510(k) K883270

IRIS ND:YAG OPTHALMIC LASER by California Laboratories, Inc. — Product Code LQJ

K883270 is an FDA 510(k) premarket notification submitted by California Laboratories, Inc. for the device "IRIS ND:YAG OPTHALMIC LASER". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), a Class II device regulated under 21 CFR 886.4390. California Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
August 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Other clearances by California Laboratories, Inc.

  • K884431 — HEXASCAN HANDPIECE FOR ARGON/DYE LASER (December 2, 1988)
  • K884694 — MQL 20 ND:YAG OPHTHALMIC LASER (November 30, 1988)
  • K875338 — CHRYS(TM) MODEL MED-MAX (April 13, 1988)

Other clearances for product code LQJ

  • K163632 — Katalyst Cyclophotocoagulation Probe (June 15, 2017)
  • K931356 — SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR (September 7, 1993)
  • K921414 — TROKEL /3 GONIO LASER LENS (November 16, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)
  • K893731 — SHIELDS T.C. LASER LENS (August 17, 1989)
  • K884694 — MQL 20 ND:YAG OPHTHALMIC LASER (November 30, 1988)
  • K883719 — INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (October 18, 1988)
  • K882574 — BOLDREY PERIPHERAL RETINAL LENS (July 29, 1988)
  • K872802 — TROKEL SINGLE MIRROR YAG LASER LENS (September 4, 1987)
  • K871245 — LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 (May 7, 1987)

FDA data resources