Byrne Expulsive Lens
FDA 510(k) K923670 · Ocular Instruments, Inc.
510(k) numberK923670
Submission
- Device name
- Byrne Expulsive Lens
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- July 22, 1992
- Decision date
- November 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HJI – Lens, Fundus, Hruby, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1395
- Specialty
- Ophthalmic
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|---|---|---|---|
| K902138 | Stripe ProjectorHJI · Traditional | Academic Catalyst Corp. | 07/05/1990SE |
| K901839 | 60 Fundus Camera CF-60UVHJI · Traditional | Canon USA, Inc. | 07/05/1990SE |
| K897186 | Laser Imaging Work StationHJI · Traditional | Innovision Medical, Inc. | 03/12/1990SE |
| K820223 | Oms Quartz Infusion Contact LensHJI · Traditional | Optical Micro Systems, Inc. | 02/05/1982SE |
| K802971 | Landers Contact LensHJI · Traditional | Cooper Medical Devices Corp. | 02/05/1981SE |
| K802927 | Sebestyen Irrigating Contact LensHJI · Traditional | Cooper Medical Devices Corp. | 02/05/1981SE |
| K760949 | Charles Irrigating Fundus Contact LensHJI · Traditional | Richard'S Medical Equip., Inc. | 11/11/1976SE |
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| 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 |
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Questions and answers
When was Byrne Expulsive Lens cleared by the FDA?
Byrne Expulsive Lens (K923670) received a 510(k) decision of Substantially Equivalent on November 16, 1992, 117 days after the submission was received.
What is the product code of K923670?
The FDA product code is HJI – Lens, Fundus, Hruby, Diagnostic, a Class I (low risk) device regulated under 21 CFR 886.1395.