Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
The Neodymium:YAG Laser for Posterior Capsulotomy and Cutting Pupillary Membranes (product code LXS) is an ophthalmic laser system that uses Nd:YAG laser energy to perform non-contact photodisruption of the posterior lens capsule following cataract surgery or to cut pupillary membranes obstructing vision. Regulated under 21 CFR 886.4392 and classified as a Class 2 device, it requires a 510(k) premarket notification and is eligible for third-party review. The device falls under the Ophthalmic specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LXS
- Device Class
- FDA class 2
- Regulation Number
- 886.4392
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023045 | MICRORUPTER V | Sep 26, 2002 | Substantially Equivalent | Meridian AG |
| K901605 | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. | Dec 13, 1990 | Substantially Equivalent | Phoenix Laser Systems, Inc. |
| K895864 | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP | Dec 29, 1989 | Substantially Equivalent | Lasag AG |
| K893987 | NIDEK MODEL YC-1200 | Aug 18, 1989 | Substantially Equivalent | Nidek, Inc. |
| K892204 | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | Jun 22, 1989 | Substantially Equivalent | Nidek, Inc. |
| K892058 | ISL QC 2000 | Jun 15, 1989 | Substantially Equivalent | Intelligent Surgical Lasers, 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 3 registration numbers. Click on an entry to view related FDA registrations.