FDA.reportPublic FDA data

BOSS

Primary DI
00860003630624
Brand
BOSS
Company
Intelon Optics, Inc.
Model
1
Device description
The Intelon BOSS instrument is intended for imaging of the cornea and crystalline lens and the measurement of the elastic properties of these ocular structures.
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MXKDevice, Analysis, Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223700000BOSS™Intelon Optics, Inc.2024-08-16MXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003630624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003630624008600036306248600036306240860003630624

GMDN Terms#

Term, Definition table
TermDefinition
Ocular tissue elasticity analyserAn ophthalmic instrument intended to use non-contact optical-scanning technology to measure the degree of elasticity, or stiffness, of the cornea and lens in the evaluation of various ocular disorders [e.g., presbyopia, keratoconus, corneal ectasia, pellucid marginal degeneration]. It consists of an electrically-powered software-assisted desktop unit, typically with a patient headrest, which provides measurement results in the form of numerical data.

Regulatory Flags#

DUNS number
078427708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
08034028770517ESSILORVISIA IMAGING SRLMXK2024-11-04
08034028770487MYAHVISIA IMAGING SRLMXK2023-10-12
03664188000060VisionixLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
04059237000730HRT3Heidelberg Engineering GmbHMXK2023-03-03
08034028770463MYOPIA EXPERT 700VISIA IMAGING SRLMXK2022-06-22
08034028770456MYAHVISIA IMAGING SRLMXK2022-06-14
04049584025357Pentacam AXL WaveOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04049584029942Myopia MasterOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04049584029959Myopia MasterOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04059237000747TOMOCAPHeidelberg Engineering GmbHMXK2020-10-29
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
03664188000046VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
03664188000909VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
07640167751242GALILEISIS AG, Surgical Instrument SystemsMXK2019-09-20
04573344510024OPTICAL BIOMETERSANTEC CORPORATIONMXK2019-05-22
04059237000334HRT3 Heidelberg Engineering GmbHMXK2017-07-14
04573344510017OPTICAL BIOMETER SANTEC CORPORATIONMXK2017-05-01
04059237000242SPECTRALIS, HRT3, HEPHeidelberg Engineering GmbHMXK2016-12-16
04059237000266HRT3Heidelberg Engineering GmbHMXK2016-09-24
04059237000273HRT3 Heidelberg Engineering GmbHMXK2016-09-24
03664188002200VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23
03664188001203VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23