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510(k) K882574

BOLDREY PERIPHERAL RETINAL LENS by Ocular Instruments, Inc. — Product Code LQJ

K882574 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "BOLDREY PERIPHERAL RETINAL LENS". The FDA issued a decision of Substantially Equivalent on July 29, 1988. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), a Class II device regulated under 21 CFR 886.4390. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1988
Date Received
June 22, 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 Ocular Instruments, Inc.

  • K014170 — STAURENGHI WIDE FIELD SCANNING LASER LENS (March 4, 2002)
  • K012096 — DISPOSABLE VITRECTOMY LENS (August 24, 2001)
  • K933976 — MANDELKORN SUTURE LYSIS LENS (November 8, 1994)
  • K933264 — RITCH NYLON SUTURE LASER LENS (October 31, 1994)
  • K941420 — 50 DEGREE HRI PRISM LENS (August 29, 1994)
  • K935302 — OSHER SURGICAL GONIO/POSTERIOR POLE LENS (April 1, 1994)
  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K921414 — TROKEL /3 GONIO LASER LENS (November 16, 1992)
  • K914051 — PEDIATRIC VITRECTOMY LENS SET (December 9, 1991)
  • K914117 — LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (November 13, 1991)

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)
  • K883270 — IRIS ND:YAG OPTHALMIC LASER (October 13, 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