Supra Twin Ophthalmic Laser Photocoagulator
FDA 510(k) K081946 · Quantel Medical
510(k) numberK081946
Submission
- Device name
- Supra Twin Ophthalmic Laser Photocoagulator
- Applicant
- Quantel Medical
Hasbrouck Heights, NJ, US - Received
- July 8, 2008
- Decision date
- March 25, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code HQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610)HQF · Traditional | Belkin Vision, Ltd. | 04/07/2026SE |
| K251507 | Integre LioHQF · Traditional | Quantel Medical | 02/06/2026SE |
| K251772 | Navilas Laser System 577sl (156691)HQF · Traditional | Od-Os GmbH | 10/29/2025SE |
| K243014 | EyeQ nanoECPHQF · Traditional | Eyeq, Inc. | 06/18/2025SE |
| K240615 | Leos Laser and Endoscopy SystemHQF · Traditional | Beaver-Visitec International, Inc. | 04/03/2025SE |
| K242397 | LYNX PhotocoagulatorHQF · Traditional | Norlase Aps | 10/25/2024SE |
| K233911 | VISULAS combiHQF · Traditional | Carl Zeiss Meditec, AG | 09/06/2024SE |
| K232417 | MR Q; MR Q Supine; MR Q SLTHQF · Traditional | Meridian AG | 01/25/2024SE |
| K230722 | Eagle deviceHQF · Traditional | Belkin Vision, Ltd. | 12/08/2023SE |
| K232051 | VISULAS greenHQF · Traditional | Carl Zeiss Meditec | 10/24/2023SE |
More from Carl Zeiss Meditec
| 510(k) | Device | Decision |
|---|---|---|
| K251507 | Integre LioHQF · Traditional | 02/06/2026SE |
| K232302 | Pocket IIIIYO · Traditional | 04/26/2024SE |
| 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 |
| K140336 | Optimus Fusion: SLT, Yag and Yag/SltHQF · Traditional | 06/25/2014SE |
Questions and answers
When was Supra Twin Ophthalmic Laser Photocoagulator cleared by the FDA?
Supra Twin Ophthalmic Laser Photocoagulator (K081946) received a 510(k) decision of Substantially Equivalent on March 25, 2009, 260 days after the submission was received.
What is the product code of K081946?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.