Medtronic Solan Fiberoptic Corneal Light Probe
FDA 510(k) K000728 · Medtronic Xomed
510(k) numberK000728
Submission
- Device name
- Medtronic Solan Fiberoptic Corneal Light Probe
- Applicant
- Medtronic Xomed
Jacksonville, FL, US - Received
- March 6, 2000
- Decision date
- March 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Medtronic Solan Fiberoptic Corneal Light Probe cleared by the FDA?
Medtronic Solan Fiberoptic Corneal Light Probe (K000728) received a 510(k) decision of Substantially Equivalent on March 21, 2000, 15 days after the submission was received.
What is the product code of K000728?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.