Appasamy Slit Lamp A1A-11 and A1A-12 Series
510(k) K082031
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082031 | Date31 Jul 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HJO
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Appasamy Slit Lamp A1A-11 and A1A-12 Series is a biomicroscope designed for ophthalmic use, specifically for examining the anterior segment of the eye. It provides detailed visualization of structures from the cornea epithelium to the posterior capsule, enabling precise diagnostic assessment of ocular health. The device incorporates slit-lamp illumination to enhance clarity and depth perception during examinations.
This slit lamp is an AC-powered, reusable ophthalmic instrument intended for clinical settings. It is classified as a Class II medical device under FDA regulation 886.1850 and holds a 510(k) clearance (K082031) for substantial equivalence. The A1A-11 and A1A-12 models are part of the Greenough-type slit lamp category, offering adjustable slit control and high-illumination LED lighting for comprehensive anterior segment evaluation. Storage and maintenance follow standard clinical protocols for reusable ophthalmic devices.
Other devices from Appasamy Associates
Questions
AI-generated answers, 1 Oct 2026
What is the Appasamy Slit Lamp A1A-11 and A1A-12 Series used for?
The Appasamy Slit Lamp A1A-11 and A1A-12 Series is designed specifically for ophthalmic use to examine the anterior segment of the eye. This includes detailed visualization of structures from the cornea epithelium to the posterior capsule, enabling precise diagnostic assessments of ocular health. The adjustable slit control and high-illumination LED lighting enhance clarity and depth perception during examinations.
How is the Appasamy Slit Lamp A1A-11 and A1A-12 Series powered and supplied?
The Appasamy Slit Lamp A1A-11 and A1A-12 Series is an AC-powered device, meaning it requires a standard electrical outlet for operation. It is intended for reusable clinical settings, following standard maintenance protocols for reusable ophthalmic instruments.
Are the A1A-11 and A1A-12 models single-use or reusable?
The Appasamy Slit Lamp A1A-11 and A1A-12 Series are reusable devices. They are designed for clinical use and must be maintained according to standard protocols for reusable ophthalmic equipment to ensure safety, hygiene, and longevity.
What types of lighting does the Appasamy Slit Lamp A1A-11 and A1A-12 Series use?
The Appasamy Slit Lamp A1A-11 and A1A-12 Series features high-illumination LED lighting, which provides bright and clear visualization of the eye’s anterior segment. This lighting enhances diagnostic precision by improving contrast and depth perception during examinations.
How should the Appasamy Slit Lamp A1A-11 and A1A-12 Series be stored and maintained?
The Appasamy Slit Lamp A1A-11 and A1A-12 Series should be stored in a clean, dry environment, protected from dust and moisture, following standard clinical protocols for reusable ophthalmic devices. Regular maintenance, including cleaning and calibration, is essential to ensure optimal performance and longevity of the device.