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510(k) K883719

INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM by Biophysic Medical, Inc. — Product Code LQJ

K883719 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 1988. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), a Class II device regulated under 21 CFR 886.4390. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1988
Date Received
August 31, 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 Biophysic Medical, Inc.

  • K953399 — NEEDLE OR CUTTER (October 30, 1995)
  • K893035 — OPHTHASCAN 'S' MINI-A (June 12, 1989)
  • K890509 — INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM (March 24, 1989)
  • K884595 — OPHTHASCAN MINI-B (January 3, 1989)
  • K884456 — STERILE DISPOSABLE ENDOCULAR PROBE (December 9, 1988)
  • K881494 — FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER (August 30, 1988)
  • K881459 — NANOLAS ND:YAG OPHTHALMIC LASER (April 13, 1988)
  • K873460 — OPHTHALAS DYE OPHTHALMIC LASER (October 29, 1987)
  • K853116 — PAXIAL (October 31, 1985)
  • K844686 — OPHTHASCAN B (September 13, 1985)

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)
  • 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