The following data is part of a premarket notification filed by Optical Integrity, Inc. with the FDA for Optical Integrity Laserguard Fibers.
| Device ID | K100194 |
| 510k Number | K100194 |
| Device Name: | OPTICAL INTEGRITY LASERGUARD FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OPTICAL INTEGRITY, INC. 7500 MCELVEY RD. Panama City Beach, FL 32408 |
| Contact | Ronald E Bowman |
| Correspondent | Ronald E Bowman OPTICAL INTEGRITY, INC. 7500 MCELVEY RD. Panama City Beach, FL 32408 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14527750300UISHO1 | K100194 | 000 |
| B145111450 | K100194 | 000 |
| B145111430 | K100194 | 000 |
| B145111410 | K100194 | 000 |
| B145111131 | K100194 | 000 |
| B145111091 | K100194 | 000 |
| B145111051 | K100194 | 000 |
| B145111001 | K100194 | 000 |
| B145110961 | K100194 | 000 |
| B145110921 | K100194 | 000 |
| B145109660 | K100194 | 000 |
| B145109201 | K100194 | 000 |
| B145109161 | K100194 | 000 |
| B145109121 | K100194 | 000 |
| B145109081 | K100194 | 000 |
| B145107190 | K100194 | 000 |
| B145106830 | K100194 | 000 |
| B145106810 | K100194 | 000 |
| B145111490 | K100194 | 000 |
| B145112110 | K100194 | 000 |
| B145113370 | K100194 | 000 |
| B14527750300U13SH1 | K100194 | 000 |
| B14527750300U13FS1 | K100194 | 000 |
| B14527750300U1C3FS1 | K100194 | 000 |
| B14527750272U13SH1 | K100194 | 000 |
| B14527750272U13FS1 | K100194 | 000 |
| B14527750272U1C3FS1 | K100194 | 000 |
| B14527750200U13SH1 | K100194 | 000 |
| B14527750200U13FS1 | K100194 | 000 |
| B14527750200U1C3FS1 | K100194 | 000 |
| B145113760 | K100194 | 000 |
| B145113740 | K100194 | 000 |
| B145113720 | K100194 | 000 |
| B145113680 | K100194 | 000 |
| B145113660 | K100194 | 000 |
| B145113511 | K100194 | 000 |
| B145113491 | K100194 | 000 |
| B145113471 | K100194 | 000 |
| B145105370 | K100194 | 000 |