510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K153769Substantially Equivalent

R:GEN Laser System

Lutronic Corporation, Goyang-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153769 is the FDA 510(k) clearance record for R:GEN Laser System, a class II device, cleared for Lutronic Corporation on under FDA product code HQF (Laser, Ophthalmic). FDA records list 29 510(k) clearances for Lutronic Corporation, from to . As of , FDA records show no recalls naming K153769.

Clearance record

Decision date
Received
(280 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Lutronic Corporation 219, Sowon-Ro, Deogyang-Gu, Goyang-Si, KR
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