LQJ · Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Ophthalmic · 21 CFR 886.4390 · Class 2
Overview
| Product Code | LQJ |
|---|---|
| Device Name | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Regulation | 21 CFR 886.4390 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
Classification Rationale
Class II.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163632 | Katalyst Cyclophotocoagulation Probe | Katalyst Surgical, LLC | Jun 15, 2017 | SESE |
| K931356 | SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR | Sorenson Laboratories, Inc. | Sep 7, 1993 | SESE |
| K921414 | TROKEL /3 GONIO LASER LENS | Ocular Instruments, Inc. | Nov 16, 1992 | SESE |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | Tomey Corporation USA | Jun 17, 1991 | SESE |
| K893731 | SHIELDS T.C. LASER LENS | Ocular Instruments, Inc. | Aug 17, 1989 | SESE |
| K884694 | MQL 20 ND:YAG OPHTHALMIC LASER | California Laboratories, Inc. | Nov 30, 1988 | SESE |
| K883719 | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | Biophysic Medical, Inc. | Oct 18, 1988 | SESE |
| K883270 | IRIS ND:YAG OPTHALMIC LASER | California Laboratories, Inc. | Oct 13, 1988 | SESE |
| K882574 | BOLDREY PERIPHERAL RETINAL LENS | Ocular Instruments, Inc. | Jul 29, 1988 | SESE |
| K872802 | TROKEL SINGLE MIRROR YAG LASER LENS | Ocular Instruments, Inc. | Sep 4, 1987 | SESE |
| K871245 | LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 | Chiron Vision Corp. | May 7, 1987 | SESE |
| K871099 | SCHIRMER NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | Apr 27, 1987 | SESE |
| K862869 | PETRUS SINGLE MIRROR LASER LENS | Ocular Instruments, Inc. | Aug 21, 1986 | SESE |
Top Applicants
- Ocular Instruments, Inc. — 6 clearances
- California Laboratories, Inc. — 2 clearances
- Tomey Corporation USA — 1 clearance
- Sorenson Laboratories, Inc. — 1 clearance
- Katalyst Surgical, LLC — 1 clearance
