FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Vitreq disposable laser probes, light fibers and Chandelier
K Number: K182646
·
Decision May 1, 2019
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
2
Review Days
219
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Basic Information
- Device Name
- Vitreq disposable laser probes, light fibers and Chandelier
- K Number
- K182646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VitreQ BV
- Date Received
- September 24, 2018
- Decision Date
- May 1, 2019
- Product Code
- HQB
- 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 |
|---|---|---|---|
| HQB | Photocoagulator And Accessories | FDA class 2 | Ophthalmic |
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Other Clearances by VitreQ BV
| K Number | Device Name | ||
|---|---|---|---|
| K202038 | CryoTreQ | Dec 30, 2020 | Substantially Equivalent |