The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Lutex Headlight Systems.
| Device ID | K864380 |
| 510k Number | K864380 |
| Device Name: | LUTEX HEADLIGHT SYSTEMS |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge, MA 01566 |
| Contact | Thomas Wilk |
| Correspondent | Thomas Wilk LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge, MA 01566 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1986-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M40500290091 | K864380 | 000 |
| M433001387LX1 | K864380 | 000 |
| M433001380LX1 | K864380 | 000 |
| M433001370LX1 | K864380 | 000 |
| M4330013371 | K864380 | 000 |
| M4330013281 | K864380 | 000 |
| M433001290BIFREP1 | K864380 | 000 |
| M433001290BIF01 | K864380 | 000 |
| M433001270BIF1 | K864380 | 000 |
| M433001234LX1 | K864380 | 000 |
| M433001170BIF1 | K864380 | 000 |
| M4330002861 | K864380 | 000 |
| M433495361 | K864380 | 000 |
| M4334003551 | K864380 | 000 |
| M433400282LX1 | K864380 | 000 |
| M433004810LX1 | K864380 | 000 |
| M405001388LX111 | K864380 | 000 |
| M405001388LX91 | K864380 | 000 |
| M405002900111 | K864380 | 000 |
| M4050023009S1 | K864380 | 000 |
| M4050023009G1 | K864380 | 000 |
| M40500230091 | K864380 | 000 |
| M405002242A1 | K864380 | 000 |
| H834D052750011 | K864380 | 000 |
| M433AX2100BIF1 | K864380 | 000 |
| M433AX1385BIF1 | K864380 | 000 |
| M433AX1375BIF1 | K864380 | 000 |
| M43390013PX1 | K864380 | 000 |
| M43390012PX1 | K864380 | 000 |
| M433005331LX1 | K864380 | 000 |
| M43304715LX1 | K864380 | 000 |
| M433002008LX1 | K864380 | 000 |
| M433001775LX1 | K864380 | 000 |
| M4330011901 | K864380 | 000 |