Schirmer Nylon Suture Laser Lens
FDA 510(k) K871099 · Ocular Instruments, Inc.
510(k) numberK871099
Submission
- Device name
- Schirmer Nylon Suture Laser Lens
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- March 19, 1987
- Decision date
- April 27, 1987
- 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
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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 |
| K883719 | Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional | Biophysic Medical, Inc. | 10/18/1988SE |
| 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 |
More from Ocular Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K014170 | Staurenghi Wide Field Scanning Laser LensHJK · Traditional | 03/04/2002SE |
| K012096 | Disposable Vitrectomy LensHJK · Traditional | 08/24/2001SE |
| K933976 | Mandelkorn Suture Lysis LensHJK · Traditional | 11/08/1994SE |
| K933264 | Ritch Nylon Suture Laser LensHJK · Traditional | 10/31/1994SE |
| K941420 | 50 Degree Hri Prism LensHJK · Traditional | 08/29/1994SE |
| K935302 | Osher Surgical Gonio/Posterior Pole LensHKS · Traditional | 04/01/1994SE |
| K923670 | Byrne Expulsive LensHJI · Traditional | 11/16/1992SE |
| K921414 | Trokel /3 Gonio Laser LensLQJ · Traditional | 11/16/1992SE |
| K914051 | Pediatric Vitrectomy Lens SetHJK · Traditional | 12/09/1991SE |
| K914117 | Landers High Refractive Index Vitrectomy Lens SetHJK · Traditional | 11/13/1991SE |
Questions and answers
When was Schirmer Nylon Suture Laser Lens cleared by the FDA?
Schirmer Nylon Suture Laser Lens (K871099) received a 510(k) decision of Substantially Equivalent on April 27, 1987, 39 days after the submission was received.
What is the product code of K871099?
The FDA product code is LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.