510(k) K220506
- Device
- SkinPen Precision System
- Applicant
- Crown Aesthetics
- 510(k) number
- K220506
- Product code
- QAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-07
- Date received
- 2022-02-22
- Regulation
- 878.4430
- Classification name
- Powered Microneedle Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Marie Fogartie
- Address
- 5005 Lyndon B. Johnson Frwy, Suite 370 Dallas TX US 75244 75244
FDA Registration Numbers
- 3007047889
- 3014170143
- 3023808190
- 3020160672
- 3022327202
- 2182318
- 3012481754
- 3011637800
- 3015610860
- 3007544634
- 3033273466
- 9617429
- 3008717566
- 3020704367
- 3017132875
- 3015452693
- 3007361698
- 3035372180
- 3006033709
- 3018153007
- 3007712511
- 8040537
- 3043657394
- 3016420624
- 3005382983
- 3011765094
- 3010893595
- 3004920696
- 3013360665
- 3006634874
- 3006515340
- 3010290186
- 3007645866
- 3031233197
- 3017896194
- 1930126
- 3030446758
- 3010392991
- 3010126182
- 3009435759
- 3016899893
- 3010763671
- 3042225401
- 3005064943
- 3031462230
- 3017065670
- 3031233199
- 1000561585
- 3016453096
- 1928237
- 3038871368
- 3030126373
- 3009649442
- 3011568699
- 3010882708
Source Documents
Other 510(k) Records For Product Code QAI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | 2026-02-19 |
| K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | 2025-10-30 |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025-10-29 |
| K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | 2025-08-25 |
| K243143 | E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. | 2025-04-07 |
| K243472 | 1NEED Pro | Campomats S.R.L. | 2025-03-19 |
| K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | 2025-03-06 |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024-10-09 |
| K233709 | Exceed Unlimited | Mt. Derm GmbH | 2024-02-23 |
| K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 |
| K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | 2023-07-28 |
| K221011 | AI.ME System | Venus Concept USA, Inc. | 2022-12-20 |
| K221070 | DP4 Microneedling device | Equipmed USA, LLC | 2022-12-20 |
| K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022-10-21 |