510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853812Substantially Equivalent

Photron Neurovisual Stimulator(modification)

Biosan Laboratories, Inc., San Rafael CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853812 is the FDA 510(k) clearance record for PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION), a class II device, cleared for Biosan Laboratories, Inc. on under FDA product code HLX (Photostimulator, Ac-Powered). FDA records list 10 510(k) clearances for Biosan Laboratories, Inc., from to . As of , FDA records show no recalls naming K853812.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HLX Photostimulator, Ac-Powered
Regulation
21 CFR 886.1630
Device class
Class II
Review panel
Ophthalmic
Applicant
Biosan Laboratories, Inc. 1016 C St., San Rafael CA
Third party review
No

Clearances, product code HLX

Trailing 12 months

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

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