Device Type ID | 5522 |
Device Name | Light, Ultraviolet, Dermatological |
Regulation Description | Ultraviolet Lamp For Dermatologic Disorders. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(k) |
CFR Regulation Number | 878.4630 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FTC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 5522 |
Device | Light, Ultraviolet, Dermatological |
Product Code | FTC |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Ultraviolet Lamp For Dermatologic Disorders. |
CFR Regulation Number | 878.4630 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
CLARTEIS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DAAVLIN | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DAAVLIN CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GME (GERMAN MEDICAL ENGINEERING) GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTEK LIGHTING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 |
Device Problems | |
---|---|
Improper Or Incorrect Procedure Or Method | 3 |
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Incorrect Control Settings | 1 |
Inadequate Or Insufficient Training | 1 |
Insufficient Information | 1 |
Total Device Problems | 9 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | National Biological Corp | II | Mar-20-2017 |