Definition: This Product Code Is The Class II Exempt Counterpart Of HJO, 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 | 4411 |
| Device Name | Biomicroscope, Slit-lamp, Ac-powered, Exempt |
| Physical State | Exemption Is Limited To Slit-lamp, AC-powered Biomicroscopes Intended Only For The Visual Examination Of The Anterior Segment Of The Eye, Are Classified As Group 1 Per FDA-recognized Consensus Standard ANSI Z80.36, Do Not Provide Any Quantitative Out |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of HJO, 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 HJO, 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 | AC-powered Slitlamp Biomicroscope. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 886.1850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4411 |
| Device | Biomicroscope, Slit-lamp, Ac-powered, Exempt |
| Product Code | PUE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AC-powered Slitlamp Biomicroscope. |
| CFR Regulation Number | 886.1850 [🔎] |