The following data is part of a premarket notification filed by Laseroptek Co., Ltd. with the FDA for Lotus Iii Multi-pulsed Er: Yag Laser System.
| Device ID | K182045 |
| 510k Number | K182045 |
| Device Name: | Lotus III Multi-Pulsed Er: Yag Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Laseroptek Co., Ltd. #116, #117, #203, #204, Hyundai I Valley 31, Galmachi-Ro, Jungwon-Gu Seongnam-si, KR 13212 |
| Contact | Hong Chu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2018-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035500603 | K182045 | 000 |
| 08800035501136 | K182045 | 000 |