The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Luxtec Aco Series 4000 Light Source.
| Device ID | K890716 |
| 510k Number | K890716 |
| Device Name: | LUXTEC ACO SERIES 4000 LIGHT SOURCE |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge, MA 01566 |
| Contact | Bruce K Packard |
| Correspondent | Bruce K Packard LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge, MA 01566 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-04-26 |