Mamiya Slit Lamp P-1
by Okada Corp.
510(k) K843099
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843099 | Date21 Nov 1984 | 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- Withdrawn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
- HLI
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1570
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mamiya Slit Lamp P-1 is an ophthalmic diagnostic device classified as an ac-powered ophthalmoscope. It is designed to illuminate and magnify the anterior segment of the eye, enabling detailed examination of structures such as the cornea, iris, lens, and anterior chamber. This examination aids in the diagnosis of ocular conditions, including cataracts, glaucoma, and corneal abnormalities, by providing a high-contrast, cross-sectional view of the eye’s anatomy.
The device is supplied as a reusable, non-sterile instrument intended for clinical use in ophthalmology settings. It operates on alternating current (AC) power and is classified under FDA regulation number 886.1570 with a product code of HLI. The Mamiya Slit Lamp P-1 received FDA 510(k) clearance (K843099) in 1984 under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a predicate device. Storage and maintenance instructions are not specified in the regulatory data but should follow standard ophthalmic equipment protocols to ensure proper functionality and hygiene.
Questions
AI-generated answers, 1 Oct 2026
What is the Mamiya Slit Lamp P-1 used for?
The Mamiya Slit Lamp P-1 is designed to examine the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber. By providing a high-contrast, cross-sectional view, it helps clinicians diagnose conditions such as cataracts, glaucoma, and corneal abnormalities with precision.
Is the Mamiya Slit Lamp P-1 reusable or single-use?
The Mamiya Slit Lamp P-1 is supplied as a reusable instrument, intended for repeated clinical use in ophthalmology settings. Proper cleaning, maintenance, and adherence to standard ophthalmic equipment protocols are essential to ensure functionality and hygiene between uses.
How is the Mamiya Slit Lamp P-1 powered?
This device operates on alternating current (AC) power, meaning it requires a standard electrical outlet to function. Ensure the power source matches the device’s voltage and frequency requirements for safe and reliable operation.
What regulatory clearance does the Mamiya Slit Lamp P-1 hold?
The Mamiya Slit Lamp P-1 received FDA 510(k) clearance (K843099) in 1984 under the Traditional 510(k) review pathway. This clearance demonstrates substantial equivalence to a predicate device and confirms its compliance with U.S. regulatory standards for ophthalmic diagnostic equipment.
Are there specific storage instructions for the Mamiya Slit Lamp P-1?
While detailed storage instructions are not explicitly provided in the regulatory data, standard protocols for ophthalmic equipment should be followed. This includes keeping the device in a clean, dry environment, protected from dust and moisture, and ensuring proper handling to maintain its functionality and longevity.