510(k) K100644
- Device
- OPTOS LIMITED PANORAMIC 200CAF
- Applicant
- OPTOS PLC
- 510(k) number
- K100644
- Product code
- MYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-15
- Date received
- 2010-03-05
- Regulation
- 886.1570
- Classification name
- Ophthalmoscope, Laser, Scanning
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN
- Address
- 555 Thirteenth St., NW Columbia Sq. Washington DC US 20004 20004
FDA Registration Numbers#
- 3002807715
- 3008348697
- 3010394097
- 3011223751
- 3005744933
- 2918630
- 3008422902
- 3013403214
- 3017133887
- 8030392
- 9617167
- 3009973692
- 2936921
- 8043762
Source Documents#
Other 510(k) Records For Product Code MYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | 2025-04-22 |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | 2025-03-17 |
| K213705 | DRSplus | Centervue S.P.A. | 2021-12-21 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | 2021-08-19 |
| K192113 | DRSplus | Centervue S.P.A. | 2019-11-15 |
| K180526 | EIDON FA | Centervue S.P.A. | 2018-07-16 |
| K180293 | Retia 2 | Centervue S.P.A. | 2018-05-30 |
| K153181 | MAIA | Centervue S.P.A. | 2016-06-08 |
| K150320 | COMPASS | Centervue S.P.A. | 2015-06-30 |
| K142897 | P200DTx | Optos Plc. | 2015-01-16 |
| K142047 | EIDON | Centervue S.P.A. | 2014-11-12 |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | 2014-04-11 |
| K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Freedom Meditech, Inc. | 2013-01-31 |
| K111988 | EASYSCAN MODEL 1.2 | I-Optics BV | 2011-10-28 |
| K111628 | P200T | Optos Plc. | 2011-08-19 |
Legacy Summary#
summary
FDA Review#
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