510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K111460Substantially Equivalent

Opto Hyalus Green Laser

Opto Eletronica S/A, Sao Carlos, Sao Paulo, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111460 is the FDA 510(k) clearance record for OPTO HYALUS GREEN LASER, a class II device, cleared for Opto Eletronica S/A on under FDA product code HQF (Laser, Ophthalmic). FDA records list one 510(k) clearance for Opto Eletronica S/A. As of , FDA records show no recalls naming K111460.

Clearance record

Decision date
Received
(452 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Opto Eletronica S/A Joaquim A. R. De Souza St., Sao Carlos, Sao Paulo, BR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQF

Trailing 12 months
2 clearances under product code HQF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260