LXS — Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla Class II
FDA product code LXS covers "Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla", a Class II medical device regulated under 21 CFR 886.4392. Submissions are reviewed by the Ophthalmic panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LXS
- Device Class
- Class II
- Regulation Number
- 886.4392
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023045 | meridian | MICRORUPTER V | September 26, 2002 |
| K901605 | phoenix laser systems | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. | December 13, 1990 |
| K895864 | lasag | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP | December 29, 1989 |
| K893987 | nidek | NIDEK MODEL YC-1200 | August 18, 1989 |
| K892204 | nidek | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | June 22, 1989 |
| K892058 | intelligent surgical lasers | ISL QC 2000 | June 15, 1989 |