The following data is part of a premarket notification filed by Vitage Led Ltd with the FDA for Lightfusion Led System.
| Device ID | K162556 |
| 510k Number | K162556 |
| Device Name: | LIGHTFUSION LED SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VITAGE LED LTD THE PAVILLION, JOSSELIN ROAD Basildon, GB Ss131qb |
| Contact | Sue D'arcy |
| Correspondent | Sue D'arcy ISMART MARKETING SERVICES 129 GREEN LANES, WYLDE GREEN Sutton Coldfield, GB B735lt |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2017-03-24 |
| Summary: | summary |