Definition: This Product Code Is The Class II Exempt Counterpart Of HEX, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k))
| Device Type ID | 4087 |
| Device Name | Colposcope (and Colpomicroscope), Exempt |
| Physical State | Exemption Is Limited To Standard Colposcopes (and Colpomicroscopes) That Use Only A White Light Source, Do Not Use Filters Other Than A Green Filter, Do Not Include Image Analysis Software, And Are Not Smartphone-based. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of HEX, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Target Area | This Product Code Is The Class II Exempt Counterpart Of HEX, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Regulation Description | Colposcope. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 884.1630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4087 |
| Device | Colposcope (and Colpomicroscope), Exempt |
| Product Code | PTZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Colposcope. |
| CFR Regulation Number | 884.1630 [🔎] |