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510(k) K881459

NANOLAS ND:YAG OPHTHALMIC LASER by Biophysic Medical, Inc. — Product Code LOI

K881459 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "NANOLAS ND:YAG OPHTHALMIC LASER". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code LOI (Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary), a Class III device. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
April 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Device Class
Class III
Regulation Number
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)
  • K873460 — OPHTHALAS DYE OPHTHALMIC LASER (October 29, 1987)
  • K853116 — PAXIAL (October 31, 1985)
  • K844686 — OPHTHASCAN B (September 13, 1985)

FDA data resources