Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60
FDA 510(k) K061024 · Peregrine Surgical , Ltd.
510(k) numberK061024
Submission
- Device name
- Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60
- Applicant
- Peregrine Surgical , Ltd.
New Britain, PA, US - Received
- April 13, 2006
- Decision date
- June 21, 2006
- 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
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 |
|---|---|---|
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…MPA · Traditional | 08/05/2024SE |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorMPA · Traditional | 09/11/2015SE |
| K132614 | Peregrine Curved Illuminating Laser ProbeHQB · Special | 11/14/2013SE |
| K122997 | 23GA Curved Illuminating Laser ProbeHQB · Special | 06/26/2013SE |
| K122905 | Peregrine 23GA Curved Laser ProbeHQB · Special | 04/30/2013SE |
| K031023 | Peregrine Illuminating Laser Probe Model PD600.10HQF · Traditional | 06/27/2003SE |
| K024061 | Peregrine Straight Laser Probe, Model PD6000.00GEX · Traditional | 03/07/2003SE |
| K990518 | Peregrine Wet Set, Model PD400.00FRN · Traditional | 03/25/1999SE |
| K981907 | V.F.I.-Viscous Fluid Infusion Tubing SetMRH · Traditional | 08/04/1998SE |
| K980797 | Peregrine Fiber Optic Multi-Function ManipulatorMPA · Traditional | 05/19/1998SE |
Questions and answers
When was Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60 cleared by the FDA?
Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60 (K061024) received a 510(k) decision of Substantially Equivalent on June 21, 2006, 69 days after the submission was received.
What is the product code of K061024?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.