Who else makes this device?

Name: Xcel® 455 Slit Lamp
Brand: Xcel® 455 Slit Lamp

Ophthalmic › DiagnosticBiomicroscope, Slit-Lamp, Ac-Powered

Xcel® 455 Slit Lamp

AC powered biomicroscope that projects light into a patient's eye. The device is intended for use in examining the anterior segment of the eye, from the corneal epithelium to the posterior…

Registry build 21.09.26

AC powered biomicroscope that projects light into a patient’s eye. The device is intended for use in examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

7manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HJO
Manufacturer	City	Province	Registered as	Device types
Chongqing Kanghua Ruiming S&T Co., Ltd.	Chongqing	Chongqing	Contract manufacturer	3
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
66 Vision Tech Co., Ltd.	Suzhou	Jiangsu	Private-label distributor	24
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 Xcel® 455 Slit Lamp
Listed by	Reichert Inc., United States
FDA product code	HJO
Device type	Biomicroscope, Slit-Lamp, Ac-Powered
Device class	Class 2
Regulation	21 CFR 886.1850
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2016-09-22
Record revised	2022-12-20 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Xcel® 455 Slit Lamp
Catalogue number	Size	Status
15140		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MediWorks	Shanghai Mediworks Precision Instruments Co., Ltd.	30
S4 Optik	Costruzioni Strumenti Oftalmici C.S.O. SRL	24
Marco	Takagi Seiko Co., Ltd.	17
Gilras	U.S. Ophthalmic, L.L.C.	16
Visionix	Luneau Technology Operations	15
LED Slit Lamp	Right MFG. Co., Ltd.	13
Tiannuo / Tnmed	Lianyungang Tiannuo Optical Instrument Co., Ltd.	12
Eli Ezer	U.S. Ophthalmic, L.L.C.	12
Inami	Inami & Co., Ltd.	11
Zoom Slit Lamp	Right MFG. Co., Ltd.	8
Slit Lamp BQ 900	Haag-Streit AG	8
PolyLock Small Bone	Fusion Orthopedics, LLC	7

Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141954	2014-10-15
K063750	2006-12-20
K061330	2006-05-25

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.