CellFX System
by Pulse Biosciences, Inc 4 variants
510(k) K222075
CellFX System is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Pulse Biosciences, Inc, cleared under FDA 510(k) K222075 on 2 Sep 2022, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222075 | Date2 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K222075
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- FDA applicant
- Pulse Biosciences, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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