Laser, Photocoagulation
FDA 510(k) K782065 · Cavitron Corp.
510(k) numberK782065
Submission
- Device name
- Laser, Photocoagulation
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- December 13, 1978
- Decision date
- December 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Laser, Photocoagulation cleared by the FDA?
Laser, Photocoagulation (K782065) received a 510(k) decision of Substantially Equivalent on December 28, 1978, 15 days after the submission was received.
What is the product code of K782065?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.