Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
This ophthalmic laser surgical accessory lens is a contact lens or lens system placed on the eye during laser procedures to focus and direct the laser beam to specific intraocular structures, such as in laser trabeculoplasty, iridotomy, or retinal photocoagulation. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LQJ, regulated under 21 CFR 886.4390, within the Ophthalmic medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LQJ
- Device Class
- FDA class 2
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163632 | Katalyst Cyclophotocoagulation Probe | Jun 15, 2017 | Substantially Equivalent | Katalyst Surgical, LLC |
| K931356 | SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR | Sep 07, 1993 | Substantially Equivalent | Sorenson Laboratories, Inc. |
| K921414 | TROKEL /3 GONIO LASER LENS | Nov 16, 1992 | Substantially Equivalent | Ocular Instruments, Inc. |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | Jun 17, 1991 | Substantially Equivalent | Tomey Corporation USA |
| K893731 | SHIELDS T.C. LASER LENS | Aug 17, 1989 | Substantially Equivalent | Ocular Instruments, Inc. |
| K884694 | MQL 20 ND:YAG OPHTHALMIC LASER | Nov 30, 1988 | Substantially Equivalent | California Laboratories, Inc. |
| K883719 | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | Oct 18, 1988 | Substantially Equivalent | Biophysic Medical, Inc. |
| K883270 | IRIS ND:YAG OPTHALMIC LASER | Oct 13, 1988 | Substantially Equivalent | California Laboratories, Inc. |
| K882574 | BOLDREY PERIPHERAL RETINAL LENS | Jul 29, 1988 | Substantially Equivalent | Ocular Instruments, Inc. |
| K872802 | TROKEL SINGLE MIRROR YAG LASER LENS | Sep 04, 1987 | Substantially Equivalent | Ocular Instruments, Inc. |
| K871245 | LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 | May 07, 1987 | Substantially Equivalent | Chiron Vision Corp. |
| K871099 | SCHIRMER NYLON SUTURE LASER LENS | Apr 27, 1987 | Substantially Equivalent | Ocular Instruments, Inc. |
| K862869 | PETRUS SINGLE MIRROR LASER LENS | Aug 21, 1986 | Substantially Equivalent | Ocular Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.