510(k) K892058
- Device
- ISL QC 2000
- Applicant
- INTELLIGENT SURGICAL LASERS, INC.
- 510(k) number
- K892058
- Product code
- LXS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-15
- Date received
- 1989-03-29
- Regulation
- 886.4392
- Classification name
- Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM S KONOWITZ
- Address
- P.O. Box 85608 Rm. 2-105 San Diego CA US 92138 92138
FDA Registration Numbers#
- 3002807715
- 2936921
- 8030392
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LXS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023045 | MICRORUPTER V | Meridian AG | 2002-09-26 |
| K901605 | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. | Phoenix Laser Systems, Inc. | 1990-12-13 |
| K895864 | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP | Lasag AG | 1989-12-29 |
| K893987 | NIDEK MODEL YC-1200 | Nidek, Inc. | 1989-08-18 |
| K892204 | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | Nidek, Inc. | 1989-06-22 |
Legacy Summary#
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FDA Review#
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