Optical Coherence Tomography HOCT-1F HOCT-1F

GUDID 08800019600497

It is intended for use as a diagnostic device to aid in the check and management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy, aged related macular degeneration, and so on

Huvitz Co., Ltd.

Spectral-domain optical coherence tomography system
Primary Device ID08800019600497
NIH Device Record Keyccdd00c6-b401-4461-939a-e41c27ea8697
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptical Coherence Tomography HOCT-1F
Version Model NumberHOCT-1F
Catalog NumberHOCT-1F
Company DUNS688154202
Company NameHuvitz Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82314289100
Emailsvc@huvitz.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019600497 [Primary]

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-20
Device Publish Date2019-05-10

Devices Manufactured by Huvitz Co., Ltd.

08800019600787 - Optical Biometer HBM-12023-10-26 The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature
08800019600916 - Digital Refractor HDR-7100P2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p
08800019600923 - Auto Ref/Keratometer HRK-8100A2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref
08800019600411 - Applanation Tonometer HT-50002023-06-20 Applanation Tonometer HT-5000
08800019600435 - Non-contact Tonometer HNT-1P2023-06-20 Non-contact Tonometer HNT-1P
08800019600503 - Ref-Keratometer ERK-91002023-06-20 Ref-Keratometer ERK-9100
08800019600558 - Auto Tono/Refracto/Kerato/Pachymeter HTR-1A2023-06-20 Auto Tono/Refracto/Kerato/Pachymeter HTR-1A
08800019600732 - Digital Chart HDC-9100N2023-06-20 Digital Chart HDC-9100N

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.