1 Series Phototherapy Equipment
FDA 510(k) clearance K220840 · decided 2022-04-22
Clearance details
- K-number
- K220840
- Device name
- 1 Series Phototherapy Equipment
- Applicant
- Daavlin Distributing Co.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-23
- Decision date
- 2022-04-22
- Days to decision
- 30 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Daavlin Distributing Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders suc recall (Z-2295-2026) | Daavlin Distributing Company | 2026-06-02 |