510(k) K203665
- Device
- STOP U Model UXV Device
- Applicant
- Pollogen Ltd.
- 510(k) number
- K203665
- Product code
- PAY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-25
- Date received
- 2020-12-16
- Regulation
- 878.4420
- Classification name
- Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ayala Kamil
- Address
- 6 Kaufman St. Tel Aviv IL 6801298 6801298
FDA Registration Numbers#
- 3007048256
- 3011070163
- 3019015047
- 3020659203
- 3014737458
- 3033793026
- 3008753275
- 3013917867
- 3016076077
- 3038373471
- 3039304811
- 3027645761
- 3011307265
- 3007238544
- 3008085016
- 3017132875
- 3018994966
- 2953684
- 3043729119
- 3012104022
Source Documents#
Other 510(k) Records For Product Code PAY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026-01-06 |
| K242227 | GENEO X ELITE | Pollogen, Ltd. | 2025-10-12 |
| K240616 | FAQ™ (102) | Foreo, Inc. | 2024-07-15 |
| K233766 | Geneo X Elite | Pollogen, Ltd. | 2024-05-07 |
| K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | 2024-03-06 |
| K230013 | Silk'n Titan Allways | Silk'N Beauty , Ltd. | 2023-08-30 |
| K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023-05-04 |
| K222012 | FAQ 101 | Foreo, Inc. | 2023-04-05 |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | 2019-06-19 |
| K170499 | sensiLift | El Global Trade, Ltd. | 2017-06-15 |
| DEN150005 | Newa Skin Therapy System | Endymed Medical, Ltd. | 2015-12-18 |
Legacy Summary#
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FDA Review#
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