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Ophthalmic › DiagnosticTonometer, Manual

Ocu-Dot® Tonometer Probes – 100 Count

The Ocu-Dot Tonometer Probe is the disposable contact accessory used by the Reichert Tono-Vera tonometer to measure intraocular pressure. It is required for both the standard-battery and…

Registry build 21.09.26

The Ocu-Dot Tonometer Probe is the disposable contact accessory used by the Reichert Tono-Vera tonometer to measure intraocular pressure. It is required for both the standard-battery and rechargeable Tono-Vera models.

The tonometer propels the small plastic-tipped probe toward the unanaesthetised cornea in a controlled movement. It detects and analyses the probe’s motion during brief contact to calculate eye pressure.

Probe Supply

Model 16318 is supplied sterile for a single use. The probe works with the compatible Tono-Vera instrument, which provides alignment, calculation and display functions.

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).

Chinese manufacturers registered for FDA product code HKY
Manufacturer	City	Province	Registered as	Device types
Beijing Hongdee Corporation	Beijing	Beijing	Private-label distributor	43
Taizhou City K&W International Trade Co., Ltd.	Jiangyan	Jiangsu	Repacker / relabeller	38
Lianyungang Tiannuo Optical Instrument Co., Ltd.	Lianyungang	Jiangsu	Contract manufacturer	31
Shanghai Mediworks Precision Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	13
Chongqing Sunkingdom Medical Instrument Co., Ltd.	Chongqing	Chongqing	Manufacturer	11

Record

Regulatory record for Ocu-Dot® Tonometer Probes – 100 Count
Listed by	Reichert Inc., United States
FDA product code	HKY
Device type	Tonometer, Manual
Device class	Class 2
Regulation	21 CFR 886.1930
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K233516
Record published	2025-08-12

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Ocu-Dot® Tonometer Probes – 100 Count
Catalogue number	Size	Per pack	Status
16318		100	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tonometer AT 900	Haag-Streit AG	7
Ambler Surgical	Ambler Surgical, LLC	7
Ocu-Film® +”	Reichert Inc.	5
Bausch + Lomb	Bausch & Lomb Incorporated	5
AccuTip Cover	Accutome, Inc.	4
Mediworks	Shanghai Mediworks Precision Instruments Co., Ltd.	4
Applanation Tonometer	Chongqing Sunkingdom Medical Instrument Co., Ltd.	3
Icare ic200	Icare Finland Oy	3
Marco	Takagi Seiko Co., Ltd.	2
S4 Optik	Costruzioni Strumenti Oftalmici C.S.O. SRL	2
iCare PATIENT2	Icare Finland Oy	2
Tonometer AT 870	Haag-Streit AG	2

Showing 12 of 71. All products under Tonometer, Manual

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233516	2024-05-01
K070534	2007-03-27

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.