Interconn. of Ophthalas & Nanolas Laser System
FDA 510(k) K883719 · Biophysic Medical, Inc.
510(k) numberK883719
Submission
- Device name
- Interconn. of Ophthalas & Nanolas Laser System
- Applicant
- Biophysic Medical, Inc.
Pleasant Hill, CA, US - Received
- August 31, 1988
- Decision date
- October 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
Other 510(k)s with product code LQJ
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|---|---|---|---|
| K163632 | Katalyst Cyclophotocoagulation ProbeLQJ · Traditional | Katalyst Surgical, LLC | 06/15/2017SE |
| K931356 | Safe Air Vari-Spot Handpiece Telescope and AdaptorLQJ · Traditional | Sorenson Laboratories, Inc. | 09/07/1993SE |
| K921414 | Trokel /3 Gonio Laser LensLQJ · Traditional | Ocular Instruments, Inc. | 11/16/1992SE |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480LQJ · Traditional | Tomey Corporation USA | 06/17/1991SE |
| K893731 | Shields T.C. Laser LensLQJ · Traditional | Ocular Instruments, Inc. | 08/17/1989SE |
| K884694 | MQL 20 Nd:Yag Ophthalmic LaserLQJ · Traditional | California Laboratories, Inc. | 11/30/1988SE |
| K883270 | Iris Nd:Yag Opthalmic LaserLQJ · Traditional | California Laboratories, Inc. | 10/13/1988SE |
| K882574 | Boldrey Peripheral Retinal LensLQJ · Traditional | Ocular Instruments, Inc. | 07/29/1988SE |
| K872802 | Trokel Single Mirror Yag Laser LensLQJ · Traditional | Ocular Instruments, Inc. | 09/04/1987SE |
| K871245 | Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1LQJ · Traditional | Chiron Vision Corp. | 05/07/1987SE |
More from Chiron Vision Corp.
| 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 |
| K881494 | Four Modifications to Ophthalas Argon/Dye LaserHQF · Traditional | 08/30/1988SN |
| 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 |
| K844686 | Ophthascan BIYO · Traditional | 09/13/1985SE |
Questions and answers
When was Interconn. of Ophthalas & Nanolas Laser System cleared by the FDA?
Interconn. of Ophthalas & Nanolas Laser System (K883719) received a 510(k) decision of Substantially Equivalent on October 18, 1988, 48 days after the submission was received.
What is the product code of K883719?
The FDA product code is LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.