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510(k) K873460

OPHTHALAS DYE OPHTHALMIC LASER by Biophysic Medical, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1987
Date Received
August 28, 1987
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)
  • K881494 — FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER (August 30, 1988)
  • K881459 — NANOLAS ND:YAG OPHTHALMIC LASER (April 13, 1988)
  • K853116 — PAXIAL (October 31, 1985)
  • K844686 — OPHTHASCAN B (September 13, 1985)

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