Peregrine 23GA Curved Laser Probe
FDA 510(k) K122905 · Peregrine Surgical , Ltd.
510(k) numberK122905
Submission
- Device name
- Peregrine 23GA Curved Laser Probe
- Applicant
- Peregrine Surgical , Ltd.
New Britain, PA, US - Received
- September 21, 2012
- Decision date
- April 30, 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 23GA Curved Laser Probe cleared by the FDA?
Peregrine 23GA Curved Laser Probe (K122905) received a 510(k) decision of Substantially Equivalent on April 30, 2013, 221 days after the submission was received.
What is the product code of K122905?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.