The following data is part of a premarket notification filed by Philips Electronics Nederland B.v. with the FDA for Philips Bluecontrol.
| Device ID | K171055 |
| 510k Number | K171055 |
| Device Name: | Philips BlueControl |
| Classification | Powered Light Based Non-laser Surgical Instrument |
| Applicant | Philips Electronics Nederland B.V. High Tech Campus 5 Eindhoven, NL 5656 Ae |
| Contact | Gaozhen Hang |
| Correspondent | Gaozhen Hang Philips Electronics Nederland B.V. High Tech Campus 5 Eindhoven, NL 5656 Ae |
| Product Code | ONE |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2017-07-06 |
| Summary: | summary |