Peregrine Curved Illuminating Laser Probe
FDA 510(k) K132614 · Peregrine Surgical , Ltd.
510(k) numberK132614
Submission
- Device name
- Peregrine Curved Illuminating Laser Probe
- Applicant
- Peregrine Surgical , Ltd.
New Britain, PA, US - Received
- August 21, 2013
- Decision date
- November 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
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Questions and answers
When was Peregrine Curved Illuminating Laser Probe cleared by the FDA?
Peregrine Curved Illuminating Laser Probe (K132614) received a 510(k) decision of Substantially Equivalent on November 14, 2013, 85 days after the submission was received.
What is the product code of K132614?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.