Supra 577.Y Laser
FDA 510(k) K091581 · Quantel Medical
510(k) numberK091581
Submission
- Device name
- Supra 577.Y Laser
- Applicant
- Quantel Medical
Clermont-Ferrand Cedex 2, FR - Received
- June 2, 2009
- Decision date
- June 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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| 510(k) | Device | Decision |
|---|---|---|
| K251507 | Integre LioHQF · Traditional | 02/06/2026SE |
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| K220430 | CapsuloHQF · Traditional | 05/12/2022SE |
| K213254 | Axialis Ophthalmic Ultrasound SystemIYO · Traditional | 11/15/2021SE |
| K201502 | Vitra 810HQF · Traditional | 08/06/2020SE |
| K191962 | Vitra 2GEX · Traditional | 12/05/2019SE |
| K183414 | AbsoluIYO · Traditional | 03/20/2019SE |
| 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 577.Y Laser cleared by the FDA?
Supra 577.Y Laser (K091581) received a 510(k) decision of Substantially Equivalent on June 16, 2009, 14 days after the submission was received.
What is the product code of K091581?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.