| 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 |