510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030295Substantially Equivalent

Ltu-904 Portable Laser Therapy Unit

Riancorp Pty Ltd, Leesburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030295 is the FDA 510(k) clearance record for LTU-904 PORTABLE LASER THERAPY UNIT, a class II device, cleared for Riancorp Pty, Ltd. on under FDA product code NZY (Light, Lymphedema Reduction, Low Energy). FDA's definition for product code NZY reads: "Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema". FDA records list one 510(k) clearance for Riancorp Pty, Ltd. As of , FDA records show no recalls naming K030295.

Clearance record

Decision date
Received
(695 days to decision)
Product code
NZY Light, Lymphedema Reduction, Low Energy
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Riancorp Pty, Ltd. 5818 Princess Caroline Pl., Leesburg FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZY

Trailing 12 months

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

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