The following data is part of a premarket notification filed by Quantel Medical with the FDA for Q-switched Nd:yag Ophtalmic Laser (with Slit Lamp), Model Optimis Ii.
| Device ID | K043613 |
| 510k Number | K043613 |
| Device Name: | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II |
| Classification | Laser, Ophthalmic |
| Applicant | QUANTEL MEDICAL 342 SUNSET BAY RD. Hot Springs, AR 71913 |
| Contact | Roger W Barnes |
| Correspondent | Roger W Barnes QUANTEL MEDICAL 342 SUNSET BAY RD. Hot Springs, AR 71913 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-30 |
| Decision Date | 2005-03-24 |
| Summary: | summary |