FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VISULAS combi
K Number: K233911
·
Decision Sep 6, 2024
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
45
Review Days
269
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Basic Information
- Device Name
- VISULAS combi
- K Number
- K233911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, AG
- Date Received
- December 12, 2023
- Decision Date
- September 6, 2024
- Product Code
- HQF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Carl Zeiss Meditec, AG
| K Number | Device Name | ||
|---|---|---|---|
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Jan 10, 2025 | Substantially Equivalent |
| K240215 | BLUE 400; BLUE 400 S | Jun 28, 2024 | Substantially Equivalent |
| K233421 | RESCAN 700 | Mar 8, 2024 | Substantially Equivalent |
| K232944 | CALLISTO eye | Dec 21, 2023 | Substantially Equivalent |
| K232159 | QEVO System | Sep 21, 2023 | Substantially Equivalent |
| K231676 | CALLISTO eye | Aug 28, 2023 | Substantially Equivalent |
| K230858 | QUATERA 700 | Jul 31, 2023 | Substantially Equivalent |
| K213527 | FORUM | Aug 15, 2022 | Substantially Equivalent |
| K211346 | BLUE 400 | Jul 22, 2022 | Substantially Equivalent |
| K212241 | QUATERA 700 | Apr 19, 2022 | Substantially Equivalent |