The following data is part of a premarket notification filed by Laseroptek Co. Ltd. with the FDA for Lotus Ii Pulsed Er: Yag Laser System.
| Device ID | K083253 |
| 510k Number | K083253 |
| Device Name: | LOTUS II PULSED ER: YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASEROPTEK CO. LTD. 22750 HAWTHORNE BLVD. SUITE 211 Torrance, CA 90505 |
| Contact | Phillip Cheon |
| Correspondent | Phillip Cheon LASEROPTEK CO. LTD. 22750 HAWTHORNE BLVD. SUITE 211 Torrance, CA 90505 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-04 |
| Decision Date | 2009-05-15 |
| Summary: | summary |