Four Modifications to Ophthalas Argon/Dye Laser
FDA 510(k) K881494 · Biophysic Medical, Inc.
510(k) numberK881494
Submission
- Device name
- Four Modifications to Ophthalas Argon/Dye Laser
- Applicant
- Biophysic Medical, Inc.
Pleasant Hill, CA, US - Received
- April 8, 1988
- Decision date
- August 30, 1988
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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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| K853116 | PaxialIYO · Traditional | 10/31/1985SE |
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Questions and answers
When was Four Modifications to Ophthalas Argon/Dye Laser cleared by the FDA?
Four Modifications to Ophthalas Argon/Dye Laser (K881494) received a 510(k) decision of Substantially Equivalent for Some Indications on August 30, 1988, 144 days after the submission was received.
What is the product code of K881494?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.