DESCRIBE PFD Patch
FDA 510(k) clearance K172689 · decided 2017-11-29
Clearance details
- K-number
- K172689
- Device name
- DESCRIBE PFD Patch
- Applicant
- Merz North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-06
- Decision date
- 2017-11-29
- Days to decision
- 84 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
- Raleigh, NC, 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 Transparent PFD Patch (K150212) | On Light Sciences, Inc. | 2015-04-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RADIESSE 1.3CC AND 0.3CC (P050037/S148) | Merz North America, Inc. | 2025-12-12 |
| COAPTITE (P040047/S079) | Merz North America, Inc. | 2025-12-12 |
| RADIESSE INJECTABLE IMPLANT (P050052/S173) | Merz North America, Inc. | 2025-12-12 |
| Belotero Balance (+) Lidocaine Dermal Filler (P090016/S068) | Merz North America, Inc. | 2025-10-24 |
| Belotero Balance (+) Lidocaine Dermal Filler (P090016/S066) | Merz North America, Inc. | 2025-10-10 |
| COAPTITE Injectable Implant (P040047/S078) | Merz North America, Inc. | 2025-08-27 |
| RADIESSE (+) Lidocaine (P050052/S171) | Merz North America, Inc. | 2025-07-14 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S170) | Merz North America, Inc. | 2025-06-26 |