510(k) DEN150005
- Device
- Newa Skin Therapy System
- Applicant
- Endymed Medical, Ltd.
- 510(k) number
- DEN150005
- Product code
- PAY
- Decision
- Unknown (DENG)
- Decision date
- 2015-12-18
- Date received
- 2015-01-16
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Yoram Levy
- Address
- 12 Leshem St., N. Industrial Park Caesarea IL 30889 30889
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#
510(k) summary PDF not indicated by FDA
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 |
| K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021-02-25 |
| 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 |