Panels › Ophthalmic › Product code HPS · Class 2
Unit, Cryophthalmic
Regulation 886.4170
0510(k)s in 12 months (11 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in HPS
| Company | 510(k)s | Recalls |
|---|---|---|
| Mira, Inc. | 1 | 3 |
| Keeler Instruments, Inc. | 2 | 0 |
| Beaver Visitec International, Inc. | 0 | 1 |
| Dutch Ophthalmic USA, Inc. | 1 | 0 |
| Edward Weck, Inc. | 1 | 0 |
| Intermedics, Inc. | 1 | 0 |
| Keeler Optical Products , Ltd. | 1 | 0 |
| Mono Research Laboratories | 1 | 0 |
| Spembly Medical , Ltd. | 1 | 0 |
| United Surgical Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2023 | Beaver Visitec International, Inc. CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the d Open, Classified |
HPS | K202038 |
| Jun 29, 2010 | Mira, Inc. MIRA CR4060 68 mm Finger Probe
68mm surf ace x 37mm Length
Intended for the destruction of tumors. Terminated |
HPS | None listed |
| Jun 29, 2010 | Mira, Inc. MIRA CR4055 25mm Finger Probe
25mm surface x 30mm Length
Intended for the destruction of tumors. Terminated |
HPS | None listed |
| Jun 29, 2010 | Mira, Inc. MIRA CR4050 12mm Finger Probe
12mm surface x 27mm Length
Intended for the destruction of tumors. Terminated |
HPS | None listed |
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