Model 9500 Argon, Krypton & Dye Surgical Laser Sys
FDA 510(k) K854949 · CooperVision, Inc.
510(k) numberK854949
Submission
- Device name
- Model 9500 Argon, Krypton & Dye Surgical Laser Sys
- Applicant
- CooperVision, Inc.
Santa Clara, CA, US - Received
- December 10, 1985
- Decision date
- February 4, 1986
- 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 Model 9500 Argon, Krypton & Dye Surgical Laser Sys cleared by the FDA?
Model 9500 Argon, Krypton & Dye Surgical Laser Sys (K854949) received a 510(k) decision of Substantially Equivalent on February 4, 1986, 56 days after the submission was received.
What is the product code of K854949?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.