Nanolas Nd:Yag Ophthalmic Laser
FDA 510(k) K881459 · Biophysic Medical, Inc.
510(k) numberK881459
Submission
- Device name
- Nanolas Nd:Yag Ophthalmic Laser
- Applicant
- Biophysic Medical, Inc.
Pleasant Hill, CA, US - Received
- April 6, 1988
- Decision date
- April 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LOI – Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- Device class
- Class III (high risk)
More from Biophysic Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953399 | Needle or CutterKNW · Traditional | 10/30/1995SE |
| K893035 | Ophthascan 'S' Mini-AIYO · Traditional | 06/12/1989SE |
| K890509 | Indirect Ophthalmoscope Accessory Delivery SystemHQF · Traditional | 03/24/1989SE |
| K884595 | Ophthascan Mini-BIYO · Traditional | 01/03/1989SE |
| K884456 | Sterile Disposable Endocular ProbeGEX · Traditional | 12/09/1988SE |
| K883719 | Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional | 10/18/1988SE |
| K881494 | Four Modifications to Ophthalas Argon/Dye LaserHQF · Traditional | 08/30/1988SN |
| K873460 | Ophthalas Dye Ophthalmic LaserHQF · Traditional | 10/29/1987SE |
| K853116 | PaxialIYO · Traditional | 10/31/1985SE |
| K844686 | Ophthascan BIYO · Traditional | 09/13/1985SE |
Questions and answers
When was Nanolas Nd:Yag Ophthalmic Laser cleared by the FDA?
Nanolas Nd:Yag Ophthalmic Laser (K881459) received a 510(k) decision of Substantially Equivalent on April 13, 1988, 7 days after the submission was received.
What is the product code of K881459?
The FDA product code is LOI – Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary, a Class III (high risk) device.