510(k) K182986
- Device
- Boston Keratoprosthesis, Type I Lucia
- Applicant
- Massachusetts Eye And Ear Infirmary D/b/a Boston
- 510(k) number
- K182986
- Product code
- HQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-30
- Date received
- 2018-10-29
- Regulation
- 886.3400
- Classification name
- Keratoprosthesis, Permanent Implant
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- James Chodosh
- Address
- Keratoprosthesis 243 Charles St. Boston MA US 02114 02114
FDA Registration Numbers#
- 3012483804
- 1047843
- 3010798453
- 1222945
Source Documents#
Other 510(k) Records For Product Code HQM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | 2013-05-10 |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | 2002-08-29 |
| K915062 | DOHLMAN DOANE KERATOPROTHESIS | Mackeen Consultants, Ltd. | 1992-01-21 |
Legacy Summary#
summary
FDA Review#
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