Indirect Ophthalmoscope Accessory Delivery System
FDA 510(k) K890509 · Biophysic Medical, Inc.
510(k) numberK890509
Submission
- Device name
- Indirect Ophthalmoscope Accessory Delivery System
- Applicant
- Biophysic Medical, Inc.
Pleasant Hill, CA, US - Received
- February 1, 1989
- Decision date
- March 24, 1989
- 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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| K883719 | Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional | 10/18/1988SE |
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| K881459 | Nanolas Nd:Yag Ophthalmic LaserLOI · Traditional | 04/13/1988SE |
| K873460 | Ophthalas Dye Ophthalmic LaserHQF · Traditional | 10/29/1987SE |
| K853116 | PaxialIYO · Traditional | 10/31/1985SE |
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Questions and answers
When was Indirect Ophthalmoscope Accessory Delivery System cleared by the FDA?
Indirect Ophthalmoscope Accessory Delivery System (K890509) received a 510(k) decision of Substantially Equivalent on March 24, 1989, 51 days after the submission was received.
What is the product code of K890509?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.