Regaltech Maxiscope
FDA 510(k) K921163 · Regaltech Pty. , Ltd.
510(k) numberK921163
Submission
- Device name
- Regaltech Maxiscope
- Applicant
- Regaltech Pty. , Ltd.
Western Australia, AU - Received
- March 11, 1992
- Decision date
- October 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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|---|---|---|---|
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| K142953 | OCT-CameraHLI · Traditional | Optomedical Technologies GmbH | 03/04/2015SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | Propper Manufacturing Co., Inc. | 09/17/2014SE |
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| K131939 | Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional | Amico Diagnostic Incorporated | 03/26/2014SE |
| K133892 | Ivue 500HLI · Traditional | Optovue, Inc. | 03/19/2014SE |
| K123316 | Heine Omega 500HLI · Abbreviated | Heine Optotechnik GmbH & Co. KG | 02/26/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | Optovue, Inc. | 01/18/2013SE |
| K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)HLI · Traditional | Bioptigen, Inc. | 05/11/2012SE |
Questions and answers
When was Regaltech Maxiscope cleared by the FDA?
Regaltech Maxiscope (K921163) received a 510(k) decision of Substantially Equivalent on October 27, 1992, 230 days after the submission was received.
What is the product code of K921163?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.