The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Led Headlight.
| Device ID | K031548 |
| 510k Number | K031548 |
| Device Name: | LED HEADLIGHT |
| Classification | Light, Headband, Surgical |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | David Klementowski |
| Correspondent | David Klementowski WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FSR |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094073089 | K031548 | 000 |
| 00732094004571 | K031548 | 000 |
| 00732094001679 | K031548 | 000 |
| 00732094001723 | K031548 | 000 |
| 00732094002485 | K031548 | 000 |
| 00732094002492 | K031548 | 000 |
| 00732094041835 | K031548 | 000 |
| 00732094071818 | K031548 | 000 |
| 00732094072143 | K031548 | 000 |
| 00732094072150 | K031548 | 000 |
| 00732094072167 | K031548 | 000 |
| 00732094072174 | K031548 | 000 |
| 00732094072198 | K031548 | 000 |
| 00732094073065 | K031548 | 000 |
| 00732094073072 | K031548 | 000 |
| 00732094004564 | K031548 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LED HEADLIGHT 90894279 not registered Live/Pending |
Solaris Lumenis inc 2021-08-20 |