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510(k) K223700

Device
BOSS?
Applicant
Intelon Optics, Inc.
510(k) number
K223700
Product code
MXK
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-16
Date received
2022-12-12
Regulation
886.1850
Classification name
Device, Analysis, Anterior Segment
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pavana Mysore Ganesh
Address
331 Montvale Ave. Floor 5 Woburn MA US 01801 01801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH2026-03-13
K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation2025-12-18
K222933MYAHVisia Imaging S.R.L.2023-06-29
K211868MYAHVisia Imaging S.R.L.2022-03-01
K202989Myopia MasterOculus Optikgeräte GmbH2021-07-14
K201724Pentacam AXL WaveOculus Optikgerate GmbH2020-10-21
K182659Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems2019-07-25
K191051ARGOSSantec Corporation2019-05-16
K152311Pentacam AXLOculus Optikgerate GmbH2016-01-20
K150754ARGOSSantec Corporation2015-10-02
K073508PARKONEOculus Optikgerate GmbH2008-09-11
K071183ALLEGRO OCULYZERWavelight AG2007-07-20
K052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)Heidelberg Engineering2006-01-13
K051940CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERASis Ltd., Surgical Instrument Systems2005-09-28
K041841PACHYCAMOculus Optikgerate GmbH2005-01-28