The following data is part of a premarket notification filed by Liger Medical, Llc with the FDA for Iris Thermocoagulator And Digital Colposcope.
| Device ID | K202915 |
| 510k Number | K202915 |
| Device Name: | IRIS Thermocoagulator And Digital Colposcope |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | Liger Medical, LLC 3300 North Running Creek Way, Building G, Suite G20 Lehi, UT 84043 |
| Contact | Wm. Dean Wallace |
| Correspondent | Wm. Dean Wallace Liger Medical, LLC 3300 North Running Creek Way, Building G, Suite G20 Lehi, UT 84043 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-04-23 |