DeScribe Transparent PFD Patch
FDA 510(k) clearance K150212 · decided 2015-04-20
Clearance details
- K-number
- K150212
- Device name
- DeScribe Transparent PFD Patch
- Applicant
- On Light Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-30
- Decision date
- 2015-04-20
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- PKO
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |
Recalls involving this device
No recalls on record reference this clearance.