Atlas FDA

LQJ

13 FDA 510(k) clearances · Product code

48 daysmedian time to decision
175 days90th percentile
13clearances measured

FDA profile

Official device name
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4390
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1 · 1998: 2 · 1999: 2 · 2000: 2 · 2002: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Katalyst Cyclophotocoagulation Probe (K163632)Katalyst Surgical, LLC2017-06-15
SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR (K931356)Sorenson Laboratories, Inc.1993-09-07
TROKEL /3 GONIO LASER LENS (K921414)Ocular Instruments, Inc.1992-11-16
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (K912112)Tomey Corporation USA1991-06-17
SHIELDS T.C. LASER LENS (K893731)Ocular Instruments, Inc.1989-08-17
MQL 20 ND:YAG OPHTHALMIC LASER (K884694)California Laboratories, Inc.1988-11-30
INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (K883719)Biophysic Medical, Inc.1988-10-18
IRIS ND:YAG OPTHALMIC LASER (K883270)California Laboratories, Inc.1988-10-13
BOLDREY PERIPHERAL RETINAL LENS (K882574)Ocular Instruments, Inc.1988-07-29
TROKEL SINGLE MIRROR YAG LASER LENS (K872802)Ocular Instruments, Inc.1987-09-04
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 (K871245)Chiron Vision Corp.1987-05-07
SCHIRMER NYLON SUTURE LASER LENS (K871099)Ocular Instruments, Inc.1987-04-27
PETRUS SINGLE MIRROR LASER LENS (K862869)Ocular Instruments, Inc.1986-08-21

Track LQJ automatically

Every clearance here is in the API, with alerts when new ones post.