The Endo Optiks Microprobe
FDA 510(k) K924090 · Endo Optics, Inc.
510(k) numberK924090
Submission
- Device name
- The Endo Optiks Microprobe
- Applicant
- Endo Optics, Inc.
Marlboro, NJ, US - Received
- August 13, 1992
- Decision date
- February 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
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More from Nidek Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K923600 | Endo Optiks Value PackLRO · Traditional | 03/23/1993SESK |
Questions and answers
When was The Endo Optiks Microprobe cleared by the FDA?
The Endo Optiks Microprobe (K924090) received a 510(k) decision of Substantially Equivalent on February 1, 1993, 172 days after the submission was received.
What is the product code of K924090?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.