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510(k) K931356

SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR by Sorenson Laboratories, Inc. — Product Code LQJ

K931356 is an FDA 510(k) premarket notification submitted by Sorenson Laboratories, Inc. for the device "SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR". The FDA issued a decision of Substantially Equivalent on September 7, 1993. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), a Class II device regulated under 21 CFR 886.4390. Sorenson Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1993
Date Received
March 17, 1993
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 Sorenson Laboratories, Inc.

  • K930434 — PLUMEMASTER SMOKE EVACUATION SYSTEM (November 16, 1993)
  • K920597 — HANDI-LASE CO2 SURGICAL LASER INSTRUMENT (June 4, 1992)

Other clearances for product code LQJ

  • K163632 — Katalyst Cyclophotocoagulation Probe (June 15, 2017)
  • 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)
  • 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