Cetus system, Cetus probe
FDA 510(k) clearance K170183 · decided 2017-09-27
Clearance details
- K-number
- K170183
- Device name
- Cetus system, Cetus probe
- Applicant
- A.R.C Laser GmbH
- Decision
- Substantially Equivalent
- Date received
- 2017-01-23
- Decision date
- 2017-09-27
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Nurnberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.