The following data is part of a premarket notification filed by Light-med (usa), Inc. with the FDA for Lpulsa Syl-9000 Ophthalmic Yag Laser.
| Device ID | K990075 |
| 510k Number | K990075 |
| Device Name: | LPULSA SYL-9000 OPHTHALMIC YAG LASER |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHT-MED (USA), INC. 110P VIA ESTRADA Laguna Hills, CA 92653 |
| Contact | Thomas V Keeley |
| Correspondent | Thomas V Keeley LIGHT-MED (USA), INC. 110P VIA ESTRADA Laguna Hills, CA 92653 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-11 |
| Decision Date | 1999-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826770567 | K990075 | 000 |
| 04712826770550 | K990075 | 000 |
| 04712826770543 | K990075 | 000 |
| 04712826770536 | K990075 | 000 |
| 04712826770901 | K990075 | 000 |