ISOLIGHT
Light, Surgical Headlight
PLANMECA USA, INC.
The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Isolight.
Pre-market Notification Details
| Device ID | K842358 |
| 510k Number | K842358 |
| Device Name: | ISOLIGHT |
| Classification | Light, Surgical Headlight |
| Applicant | PLANMECA USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBA |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-22 |
| Decision Date | 1984-07-31 |
Trademark Results [ISOLIGHT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOLIGHT 87196386 5402658 Live/Registered |
IsoPlexis Corporation 2016-10-07 |
 ISOLIGHT 79003804 3011613 Dead/Cancelled |
Hagenberger oHG 2004-01-29 |
 ISOLIGHT 75549878 not registered Dead/Abandoned |
Lafarge Corporation 1998-09-08 |
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