Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4390](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4390) → LQJ — Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

# LQJ · Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

_Ophthalmic · 21 CFR 886.4390 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ

## Overview

- **Product Code:** LQJ
- **Device Name:** Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
- **Regulation:** [21 CFR 886.4390](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4390)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **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.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K163632](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K163632.md) | Katalyst Cyclophotocoagulation Probe | Katalyst Surgical, LLC | Jun 15, 2017 | SESE |
| [K931356](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K931356.md) | SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR | Sorenson Laboratories, Inc. | Sep 7, 1993 | SESE |
| [K921414](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K921414.md) | TROKEL /3 GONIO LASER LENS | Ocular Instruments, Inc. | Nov 16, 1992 | SESE |
| [K912112](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K912112.md) | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | Tomey Corporation USA | Jun 17, 1991 | SESE |
| [K893731](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K893731.md) | SHIELDS T.C. LASER LENS | Ocular Instruments, Inc. | Aug 17, 1989 | SESE |
| [K884694](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K884694.md) | MQL 20 ND:YAG OPHTHALMIC LASER | California Laboratories, Inc. | Nov 30, 1988 | SESE |
| [K883719](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K883719.md) | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | Biophysic Medical, Inc. | Oct 18, 1988 | SESE |
| [K883270](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K883270.md) | IRIS ND:YAG OPTHALMIC LASER | California Laboratories, Inc. | Oct 13, 1988 | SESE |
| [K882574](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K882574.md) | BOLDREY PERIPHERAL RETINAL LENS | Ocular Instruments, Inc. | Jul 29, 1988 | SESE |
| [K872802](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K872802.md) | TROKEL SINGLE MIRROR YAG LASER LENS | Ocular Instruments, Inc. | Sep 4, 1987 | SESE |
| [K871245](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K871245.md) | LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 | Chiron Vision Corp. | May 7, 1987 | SESE |
| [K871099](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K871099.md) | SCHIRMER NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | Apr 27, 1987 | SESE |
| [K862869](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K862869.md) | PETRUS SINGLE MIRROR LASER LENS | Ocular Instruments, Inc. | Aug 21, 1986 | SESE |

## Top Applicants

- Ocular Instruments, Inc. — 6 clearances
- California Laboratories, Inc. — 2 clearances
- Biophysic Medical, Inc. — 1 clearance
- Chiron Vision Corp. — 1 clearance
- Katalyst Surgical, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ)

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