Prima Ktp Laser System
by Nidek, Inc.
510(k) K973828
Prima Ktp Laser System is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Nidek, Inc., cleared under FDA 510(k) K973828 on 5 Jan 1998, active as of 22 Oct 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 | NumberK973828 | Date5 Jan 1998 | StatusActive |
Official records
- FDA 510(k) database K973828
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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