Definition: Accessories That Attach To The Light And Assist In Magnifying, Clarifying, Enhancing The Image Being Viewed.
Device Type ID | 2740 |
Device Name | Accessories To Examination Light |
Physical State | Lens, Scopes |
Technical Method | Uses Lens To Improve The Image Of The Surface Area Being Viewed Under The Light. |
Target Area | Skin |
Regulation Description | AC-powered Medical Examination Light. |
Regulation Medical Specialty | General Hospital |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 880.6320 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | PEQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2740 |
Device | Accessories To Examination Light |
Product Code | PEQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | AC-powered Medical Examination Light. |
CFR Regulation Number | 880.6320 [🔎] |