Synergetics Directional Endoocular Laser Probe
FDA 510(k) K113857 · Synergetics, Inc.
510(k) numberK113857
Submission
- Device name
- Synergetics Directional Endoocular Laser Probe
- Applicant
- Synergetics, Inc.
O' Fallon, MO, US - Received
- December 30, 2011
- Decision date
- April 23, 2012
- 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 Synergetics Directional Endoocular Laser Probe cleared by the FDA?
Synergetics Directional Endoocular Laser Probe (K113857) received a 510(k) decision of Substantially Equivalent on April 23, 2012, 115 days after the submission was received.
What is the product code of K113857?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.