The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Luxscope.
Device ID | K973193 |
510k Number | K973193 |
Device Name: | LUXSCOPE |
Classification | Laser, Ophthalmic |
Applicant | LUXTEC CORP. 45 PONTIAC RD. Newton, MA 02168 |
Contact | Joseph Ress |
Correspondent | Joseph Ress LUXTEC CORP. 45 PONTIAC RD. Newton, MA 02168 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-25 |
Decision Date | 1997-11-21 |