510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990075Substantially Equivalent

Lpulsa Syl-9000 Ophthalmic Yag Laser

Light-Med (USA), Inc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990075 is the FDA 510(k) clearance record for LPULSA SYL-9000 OPHTHALMIC YAG LASER, a class II device, cleared for Light-Med(Usa), Inc. on under FDA product code HQF (Laser, Ophthalmic). FDA records list 4 510(k) clearances for Light-Med(Usa), Inc., from to . As of , FDA records show one recall naming K990075.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Light-Med(Usa), Inc. 110p Via Estrada, Laguna Hills CA
510(k) summary
Statement
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