ClearLink Controlled Phototherapy Equipment
FDA 510(k) clearance K182215 · decided 2018-10-29
Clearance details
- K-number
- K182215
- Device name
- ClearLink Controlled Phototherapy Equipment
- Applicant
- Daavlin Distributing Company
- Decision
- Substantially Equivalent
- Date received
- 2018-08-15
- Decision date
- 2018-10-29
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bryan, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders recall (Z-2744-2026) | Daavlin Distributing Company | 2026-07-15 |