Dermapose Access
FDA 510(k) clearance K200168 · decided 2020-04-22
Clearance details
- K-number
- K200168
- Device name
- Dermapose Access
- Applicant
- Puregraft, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-01-23
- Decision date
- 2020-04-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QPB
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Solana Beach, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Puregraft
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.
| Record | Firm | Date |
|---|---|---|
| Lipocosm Harmonic System (K251944) | Lipocosm, LLC | 2026-06-08 |
| AYON Body Contouring Systemâ„¢ (AYON SYSTEM) (K253396) | Apyx Medical Corporation | 2026-05-08 |
| LSSA (NP-200) (K252495) | Newpong Co., Ltd. | 2026-04-03 |
| AYON Body Contouring System (AYON SYSTEM) (K244050) | Apyx Medical Corporation | 2025-05-12 |
| PAL 7020 Console (K244026) | Microaire Surgical Instruments, LLC | 2025-04-25 |
| PAL Aspiration System (K242804) | Microaire Surgical Instruments, LLC | 2024-12-30 |
| AirSculpt Body Contouring System (AIRS-1-SYS) (K241835) | Cellmyx | 2024-11-27 |
| Vitruvian Liposaber (K240188) | Black & Black Surgical, Inc. | 2024-09-13 |
| Liposaver (K212969) | Lhbiomed Co., Ltd. | 2024-08-07 |
| PAL Infiltration System (K220318) | Microaire Surgical Instruments, LLC | 2022-10-14 |
| PAL System (K212024) | Microaire Surgical Instruments, LLC | 2022-06-10 |
| PAL Single-Use Cannulas (K192694) | Microaire Surgical Instruments | 2020-05-14 |
Recalls involving this device
No recalls on record reference this clearance.