The following data is part of a premarket notification filed by Ids, Ltd. with the FDA for Shiny Rpl System.
| Device ID | K181868 |
| 510k Number | K181868 |
| Device Name: | SHINY RPL System |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | IDS, Ltd. #105, Byoksan Digital Valley 3 Cha 271, Digital-ro, Guro-gu Seoul, KR 08381 |
| Contact | C.j. Park |
| Correspondent | Alexander Braun Henderson BraunSolutions 970 South Dawson Way Unit 14 Aurora, CO 80012 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809578390030 | K181868 | 000 |