Laser Photocoagulator 1520-A & K
FDA 510(k) K833533 · Britt Corp., Inc.
510(k) numberK833533
Submission
- Device name
- Laser Photocoagulator 1520-A & K
- Applicant
- Britt Corp., Inc.
Mchenry, IL, US - Received
- October 11, 1983
- Decision date
- January 30, 1984
- 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 Photocoagulator 1520-A & K cleared by the FDA?
Laser Photocoagulator 1520-A & K (K833533) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 111 days after the submission was received.
What is the product code of K833533?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.