DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
FDA 510(k) clearance K022104 · decided 2002-09-10
Clearance details
- K-number
- K022104
- Device name
- DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
- Applicant
- Daavlin Distributing Co.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-28
- Decision date
- 2002-09-10
- Days to decision
- 74 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
+ 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
No recalls on record reference this clearance.