Q-Switched Nd:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II
FDA 510(k) K043613 · Quantel Medical
510(k) numberK043613
Submission
- Device name
- Q-Switched Nd:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II
- Applicant
- Quantel Medical
Hot Springs, AR, US - Received
- December 30, 2004
- Decision date
- March 24, 2005
- 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
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Questions and answers
When was Q-Switched Nd:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II cleared by the FDA?
Q-Switched Nd:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II (K043613) received a 510(k) decision of Substantially Equivalent on March 24, 2005, 84 days after the submission was received.
What is the product code of K043613?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.