510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881459Substantially Equivalent

Nanolas Nd:yag Ophthalmic Laser

Biophysic Medical, Inc., Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881459 is the FDA 510(k) clearance record for NANOLAS ND:YAG OPHTHALMIC LASER, a class III device, cleared for Biophysic Medical, Inc. on under FDA product code LOI (Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary). FDA records list 11 510(k) clearances for Biophysic Medical, Inc., from to . As of , FDA records show no recalls naming K881459.

Clearance record

Decision date
Received
(7 days to decision)
Product code
LOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Device class
Class III
Review panel
Unknown
Applicant
Biophysic Medical, Inc. 2440 Estand Way, Pleasant Hill CA
Third party review
No

Clearances, product code LOI

Trailing 12 months

FDA records hold no clearances under product code LOI in the trailing twelve months.

FDA records show no clearances under product code LOI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260