DEVICE: TearCare System (00858027006211)
Device Identifier (DI) Information
TearCare System
FG 05031
Not in Commercial Distribution
Sight Sciences, Inc.
FG 05031
Not in Commercial Distribution
Sight Sciences, Inc.
Eyelid heat therapy system control unit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62518 | Eyelid heat therapy system control unit |
An electrically-powered ophthalmic device intended to control the application of localized heat therapy to the outer eyelid surfaces of an adult patient during treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is a portable unit intended to control the temperature applied to the eyelids via a skin surface applicator; the applicators are not included. It is intended to be used by a professional in a professional (e.g., clinical) setting.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IRT | Pad, Heating, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
260e9fac-70bf-447f-919c-6de131406e1b
August 22, 2023
4
February 01, 2017
August 22, 2023
4
February 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined