Lamp Delivery Sys.-Photocoagulation
FDA 510(k) K772213 · Varian Assoc., Inc.
510(k) numberK772213
Submission
- Device name
- Lamp Delivery Sys.-Photocoagulation
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- December 2, 1977
- Decision date
- December 13, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Lamp Delivery Sys.-Photocoagulation cleared by the FDA?
Lamp Delivery Sys.-Photocoagulation (K772213) received a 510(k) decision of Substantially Equivalent on December 13, 1977, 11 days after the submission was received.
What is the product code of K772213?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.