Supra Scan Delivery System
FDA 510(k) K120825 · Quantel Medical
510(k) numberK120825
Submission
- Device name
- Supra Scan Delivery System
- Applicant
- Quantel Medical
North Reading, MA, US - Received
- March 19, 2012
- Decision date
- September 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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| K180265 | COMPACT TOUCH Ophthalmic Ultrasound SystemIYO · Traditional | 03/02/2018SE |
| K170067 | EasyretHQF · Traditional | 07/25/2017SE |
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Questions and answers
When was Supra Scan Delivery System cleared by the FDA?
Supra Scan Delivery System (K120825) received a 510(k) decision of Substantially Equivalent on September 14, 2012, 179 days after the submission was received.
What is the product code of K120825?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.