STAAXL-3 Small Incision System TM, Phacofragmentat
FDA 510(k) K851936 · Staar Surgical Co.
510(k) numberK851936
Submission
- Device name
- STAAXL-3 Small Incision System TM, Phacofragmentat
- Applicant
- Staar Surgical Co.
Monrovia, CA, US - Received
- May 6, 1985
- Decision date
- August 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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Questions and answers
When was STAAXL-3 Small Incision System TM, Phacofragmentat cleared by the FDA?
STAAXL-3 Small Incision System TM, Phacofragmentat (K851936) received a 510(k) decision of Substantially Equivalent on August 20, 1985, 106 days after the submission was received.
What is the product code of K851936?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.