What is FDA product code ORZ?

Therapeutic application of heat and massage to the eyelids.

Ophthalmic › TherapeuticEyelid Thermal Pulsation System

TearCare MGX System – TearCare MGX SmartLids

Catalogue number FG 08785, listed by Sight Sciences, Inc., United States, under Eyelid Thermal Pulsation System. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ORZ
Manufacturer	City	Province	Registered as	Device types
Peter’s Technology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	9
Providence Enterprise Limited	Shenzhen	Guangdong	Contract manufacturer	9
Segue Xiamen Manufacturing Services, Inc	Xiamen	Fujian	Contract manufacturer	1
Shenzhen JPY ION-Tech. Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for TearCare MGX System – TearCare MGX SmartLids
Listed by	Sight Sciences, Inc., United States
FDA product code	ORZ
Device type	Eyelid Thermal Pulsation System
Device class	Class 2
Regulation	21 CFR 886.5200
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K242786
Record published	2025-04-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment atmospheric pressure 50 to 107 KiloPascal; Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 55 °C

Catalogue Numbers

Catalogue numbers for TearCare MGX System – TearCare MGX SmartLids
Catalogue number	Size	Status
FG 08785		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
iLux	Alcon Laboratories, Inc.	4
Lipiflow System Activator (Disposable)	TearScience, Inc.	2
Tearscience Activator Clear	Johnson & Johnson Surgical Vision, Inc.	2
TearCare System – TearCare SmartHub Kit	Sight Sciences, Inc.	1
Lipiflow System Activator II (Disposable	TearScience, Inc.	1
Tixel i	Novoxel Ltd.	1
TearCare System – TearCare SmartLids	Sight Sciences, Inc.	1
Tixel i HP	Novoxel Ltd.	1
Lipiflow System Console	TearScience, Inc.	1
TearCare MGX System – TearCare MGX Technology Kit	Sight Sciences, Inc.	1
Lipiflow System Activator II Cable KIT	TearScience, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K262479	2026-08-18
K252409	2026-04-27
K242786	2025-04-15
K231084	2023-12-27
K213045	2021-12-21

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2022-03-23	Class II	No Marketing Application	Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.	921

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.