Isl QC 2000
FDA 510(k) K892058 · Intelligent Surgical Lasers, Inc.
510(k) numberK892058
Submission
- Device name
- Isl QC 2000
- Applicant
- Intelligent Surgical Lasers, Inc.
San Diego, CA, US - Received
- March 29, 1989
- Decision date
- June 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4392
- Specialty
- Ophthalmic
Other 510(k)s with product code LXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023045 | Microrupter VLXS · Traditional | Meridian AG | 09/26/2002SE |
| K901605 | Phoenix Laser Systems Ophthalmic Surgical Worksta.LXS · Traditional | Phoenix Laser Systems, Inc. | 12/13/1990SE |
| K895864 | Microruptor III Syst, Q-Switched Nd:Yag Laser CompLXS · Traditional | Lasag AG | 12/29/1989SE |
| K893987 | Nidek Model YC-1200LXS · Traditional | Nidek, Inc. | 08/18/1989SE |
| K892204 | Nidek Inc. Models YC-2000 & 3000 Ophthalmic LasersLXS · Traditional | Nidek, Inc. | 06/22/1989SE |
More from Nidek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941694 | Isl QC 2000 LaserGEX · Traditional | 05/12/1994SE |
Questions and answers
When was Isl QC 2000 cleared by the FDA?
Isl QC 2000 (K892058) received a 510(k) decision of Substantially Equivalent on June 15, 1989, 78 days after the submission was received.
What is the product code of K892058?
The FDA product code is LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla, a Class II (moderate risk) device regulated under 21 CFR 886.4392.