BOSS™
FDA 510(k) clearance K223700 · decided 2024-08-16
Clearance details
- K-number
- K223700
- Device name
- BOSS™
- Applicant
- Intelon Optics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-12
- Decision date
- 2024-08-16
- Days to decision
- 613 days
- Clearance type
- Traditional
- Product code
- MXK
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Myopia Master (K202989) | Oculus Optikgeräte GmbH | 2021-07-14 |
| Pentacam AXL Wave (K201724) | Oculus Optikgerate GmbH | 2020-10-21 |
| Galilei G6 Lens Professional (K182659) | Sis Ag, Surgical Instrument Systems | 2019-07-25 |
| ARGOS (K191051) | Santec Corporation | 2019-05-16 |
| Pentacam AXL (K152311) | Oculus Optikgerate GmbH | 2016-01-20 |
| ARGOS (K150754) | Santec Corporation | 2015-10-02 |
| PARKONE (K073508) | Oculus Optikgerate GmbH | 2008-09-11 |
| ALLEGRO OCULYZER (K071183) | Wavelight AG | 2007-07-20 |
Recalls involving this device
No recalls on record reference this clearance.