The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Ims5000 Illuminated Loupes.
| Device ID | K895248 |
| 510k Number | K895248 |
| Device Name: | IMS5000 ILLUMINATED LOUPES |
| Classification | Loupe, Diagnostic/surgical |
| 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 | FSP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-21 |
| Decision Date | 1989-09-15 |