Home / 510(k) Clearances / K881494

510(k) K881494

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER by Biophysic Medical, Inc. — Product Code HQF

Clearance Details

Decision
SN ()
Decision Date
August 30, 1988
Date Received
April 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
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)
  • K883719 — INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (October 18, 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 HQF

  • K251507 — INTEGRE LIO (February 6, 2026)
  • K251772 — Navilas Laser System 577sl (156691) (October 29, 2025)
  • K243014 — EyeQ nanoECP (June 18, 2025)
  • K240615 — Leos Laser and Endoscopy System (April 3, 2025)
  • K242397 — LYNX Photocoagulator (October 25, 2024)
  • K233911 — VISULAS combi (September 6, 2024)
  • K232417 — MR Q; MR Q SUPINE; MR Q SLT (January 25, 2024)
  • K230722 — Eagle device (December 8, 2023)
  • K232051 — VISULAS green (October 24, 2023)
  • K230350 — VISULAS yag (September 22, 2023)