Slit Lamp AIA 11
510(k) K953030
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953030 | Date12 Jul 1995 | 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- Withdrawn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 Slit Lamp AIA 11 is a biomicroscope, specifically a slit-lamp device powered by alternating current (AC). It is designed for ophthalmic use, projecting a thin, intense beam of light through a control diaphragm to examine the anterior and posterior segments of the eye. This device falls under the classification of a Galilean microscope-based slit lamp, enabling detailed visualization of ocular structures.
The Slit Lamp AIA 11 is supplied as a reusable ophthalmic instrument and is intended for use in clinical settings by trained professionals. It has received FDA 510(k) clearance under the product code HJO, with a decision date of July 12, 1995. The device is regulated under the regulation number 886.1850 and is classified as a Class II medical device. No information regarding sterility or MRI safety is provided in the specifications.
Questions
AI-generated answers, 1 Oct 2026
What is the Slit Lamp AIA 11 used for?
The Slit Lamp AIA 11 is designed for ophthalmic examinations, allowing clinicians to visualize the anterior and posterior segments of the eye with precision. It projects a thin, intense beam of light through a control diaphragm, enabling detailed inspection of ocular structures such as the cornea, iris, lens, and retina. This makes it essential for diagnosing and monitoring eye conditions in clinical settings.
How is the Slit Lamp AIA 11 powered and supplied?
The Slit Lamp AIA 11 operates using alternating current (AC) power, meaning it requires a standard electrical outlet for operation. It is supplied as a reusable ophthalmic instrument, intended for use in clinical environments by trained professionals. The device is not single-use and is meant for repeated applications in a controlled setting.
Is the Slit Lamp AIA 11 sterile?
The provided specifications do not include details regarding the sterility of the Slit Lamp AIA 11. Clinicians should follow standard decontamination and sterilization protocols for reusable ophthalmic devices to ensure safe and hygienic use between patients. Always refer to manufacturer guidelines for proper cleaning and sterilization procedures.
What regulatory approval does the Slit Lamp AIA 11 hold?
The Slit Lamp AIA 11 has received FDA 510(k) clearance under product code HJO, with a decision date of July 12, 1995. It is classified as a Class II medical device under regulation number 886.1850. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness.
Are there different models or sizes available for the Slit Lamp AIA 11?
The provided data does not specify multiple models or sizes for the Slit Lamp AIA 11. It is identified as a single device type, the AC-powered Galilean biomicroscope. For variations or additional configurations, it is recommended to consult the manufacturer’s product catalog or contact their technical support for detailed specifications.