The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Miralite.
Device ID | K863246 |
510k Number | K863246 |
Device Name: | MIRALITE |
Classification | Laser, Ophthalmic |
Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Contact | Mark W Furlong |
Correspondent | Mark W Furlong MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-22 |
Decision Date | 1986-10-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIRALITE 86019975 not registered Dead/Abandoned |
Foamtec International Co., Ltd. 2013-07-25 |
MIRALITE 76691625 not registered Dead/Abandoned |
Remicalm LLC 2008-07-28 |
MIRALITE 74159333 1676646 Dead/Cancelled |
Miralite Communications, Inc. 1991-04-22 |
MIRALITE 73838158 1609947 Dead/Cancelled |
DOW CORNING CORPORATION 1989-11-13 |
MIRALITE 73488177 1327806 Dead/Cancelled |
Pierce & Stevens Chemical Corp. 1984-07-02 |
MIRALITE 73396595 1295549 Dead/Cancelled |
Edwards; James G. 1982-09-30 |
MIRALITE 73305398 1195606 Dead/Cancelled |
Miralite 1981-04-13 |