510(k) K252289
- Device
- Eva Scalp Cooling System
- Applicant
- Stemtech Medical Devices Private Limited
- 510(k) number
- K252289
- Product code
- PMC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-25
- Date received
- 2025-07-23
- Regulation
- 878.4360
- Classification name
- Scalp Cooling System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Subrai Pai
- Address
- 411, 4th Floor, Tesla Industrial Bldg. No-1 Tesla Plot No Gen-2/1/C (Part), Trans Thane Creek Industrial Area Navi Mumbai IN 400706 400706
FDA Registration Numbers#
- 3021619527
- 1648700
- 3012146457
- 3012187635
- 3008938259
- 3008888703
Source Documents#
Other 510(k) Records For Product Code PMC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211526 | Portable Scalp Cooling System | Cooler Heads Care, Inc. | 2021-10-21 |
| K191166 | DigniCap Delta | Dignitana, Inc. | 2019-06-26 |
| K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | 2018-06-07 |
| K170871 | DigniCap Scalp Cooling System | Dignitana AB | 2017-07-03 |
| K163484 | Paxman Scalp Cooler | Paxman Coolers Limited | 2017-04-17 |
| DEN150010 | Dignitana AB DigniCap System | Dignitana AB | 2015-12-08 |