SER Pen Carain MicroSystem (MP1209SP)
FDA 510(k) clearance K253153 · decided 2025-10-29
Clearance details
- K-number
- K253153
- Device name
- SER Pen Carain MicroSystem (MP1209SP)
- Applicant
- Su-Ko Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2025-10-29
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- QAI
- Device class
- 2
- Regulation number
- 878.4430
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Austin, TX, 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 |
|---|---|---|
| Automatic Micro Needle System (CODE-X) (K252591) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 |
| SkinStylus SteriLock MicroSystem (MP1209SL) (K253002) | Esthetic Medical, Inc. | 2026-02-19 |
| ellacor System with Micro-Coring Technology (K252752) | Cytrellis Biosystems, Inc. | 2025-10-30 |
| PRO Pen Microneedling System (6883) (K243800) | Dermalogica, LLC | 2025-08-25 |
| E-PEN (E-PEN) (K243143) | Bomtech Electronics Co., Ltd. | 2025-04-07 |
| 1NEED Pro (K243472) | Campomats S.R.L. | 2025-03-19 |
| XCELLARISPRO TWIST microneedling device (K241790) | Dermaroller GmbH | 2025-03-06 |
| SER Pen Carain MicroSystem (MP1209SP) (K241355) | Su-Ko Technologies, LLC | 2024-10-09 |
| SkinPen Precision Elite System (K241400) | Crown Aesthetics | 2024-08-29 |
| Exceed Unlimited (K233709) | Mt. Derm GmbH | 2024-02-23 |
| Dr. pen Microneedling System (K230420) | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 |
| SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (K231073) | Esthetic Medical, Inc. | 2023-07-28 |
Recalls involving this device
No recalls on record reference this clearance.