510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883719Substantially Equivalent

Interconn. of Ophthalas & Nanolas Laser System

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

K883719 is the FDA 510(k) clearance record for INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM, a class II device, cleared for Biophysic Medical, Inc. on under FDA product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser). FDA records list 11 510(k) clearances for Biophysic Medical, Inc., from to . As of , FDA records show no recalls naming K883719.

Clearance record

Decision date
Received
(48 days to decision)
Product code
LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Biophysic Medical, Inc. 2440 Estand Way, Pleasant Hill CA
Third party review
No

Clearances, product code LQJ

Trailing 12 months

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

FDA records show no clearances under product code LQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQJ, 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