27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula
FDA 510(k) K110951 · Alcon Research, Ltd.
510(k) numberK110951
Submission
- Device name
- 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula
- Applicant
- Alcon Research, Ltd.
Irvine, CA, US - Received
- April 4, 2011
- Decision date
- October 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
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Questions and answers
When was 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula cleared by the FDA?
27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula (K110951) received a 510(k) decision of Substantially Equivalent on October 17, 2011, 196 days after the submission was received.
What is the product code of K110951?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.