Pocket Ophthalmoscope GH
by Design Med. Corp. 510(k)
Active
510(k) K843897
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843897 | Date27 Nov 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HLJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1570
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Pocket Ophthalmoscope GH is a battery-powered ophthalmoscope designed for examining the interior structures of the eye, including the retina, optic disc, blood vessels, and posterior pole. It provides a portable solution for direct visualization of the fundus, enabling clinicians to assess retinal health and diagnose conditions such as glaucoma, diabetic retinopathy, or retinal detachment in clinical or field settings.
This device is supplied as a reusable, non-sterile instrument and is classified under FDA regulation 886.1570 as a Class II medical device. It is intended for use in ophthalmic examinations and features adjustable negative correction lenses for accommodating myopic patients. The Pocket Ophthalmoscope GH received FDA 510(k) clearance (K843897) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) issued on November 27, 1984. It includes a dust shutter for protection and is intended for use in non-MRI environments.
Other devices from Design Med. Corp.
Questions
AI-generated answers, 19 Sep 2026
What types of eye conditions can the Pocket Ophthalmoscope GH help diagnose during an examination?
The Pocket Ophthalmoscope GH is designed to examine the interior structures of the eye, including the retina, optic disc, blood vessels, and posterior pole. It enables clinicians to assess retinal health and potentially diagnose conditions such as glaucoma, diabetic retinopathy, or retinal detachment, though it is not intended to replace comprehensive diagnostic tools or professional judgment.
Is the Pocket Ophthalmoscope GH meant for single-use or can it be reused? How does this affect its maintenance?
The Pocket Ophthalmoscope GH is explicitly supplied as a reusable instrument, not single-use. Since it is non-sterile, proper cleaning and disinfection protocols must be followed between uses to ensure hygiene and prevent cross-contamination. The manufacturer’s instructions should be consulted for specific maintenance guidelines.
Does the Pocket Ophthalmoscope GH accommodate patients with myopia, and if so, how?
Yes, the Pocket Ophthalmoscope GH includes adjustable negative correction lenses, which allow clinicians to perform examinations on myopic (nearsighted) patients by compensating for their refractive error during fundus visualization.
What safety precautions should be taken when using the Pocket Ophthalmoscope GH in a clinical setting?
The device is equipped with a dust shutter for protection, and it is explicitly not intended for use in MRI environments. Additionally, since it is reusable and non-sterile, proper cleaning and disinfection between patients are critical to prevent infection. Always follow the manufacturer’s guidelines for safe operation and maintenance.
How was the regulatory pathway for the Pocket Ophthalmoscope GH determined, and what does that mean for its use?
The Pocket Ophthalmoscope GH received FDA 510(k) clearance (K843897) under the Traditional 510(k) Review pathway with a decision of Substantially Equivalent (SESE) on November 27, 1984. This means it was deemed comparable to a legally marketed predicate device at the time, confirming its safety and effectiveness for its intended use in ophthalmic examinations. The classification under FDA regulation 886.1570 as a Class II device also indicates it undergoes additional controls beyond general controls.