Identity
- Trade Name
- EC-5000 EXCIMER LASER SYSTEM FDA PMA
- Generic Name
- Excimer laser system FDA PMA
Identifiers
- PMA Number
- P970053 FDA PMA
- FDA Product Code
- LZS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The EC-5000 Excimer Laser System is an excimer laser device classified as a Class III medical device, designed for photorefractive keratectomy (PRK). It emits ultraviolet laser energy to reshape the cornea, correcting mild to moderate myopia (nearsightedness) in patients with spherical equivalents ranging from -0.75 to -13.00 diopters, without significant astigmatism (<0.75D in any meridian).
This system is intended for use in clinical settings by trained ophthalmologists to perform PRK procedures on patients aged 21 and older with stable refractive error histories. Supplied sterile for single-use, the device requires proper handling and storage as per manufacturer guidelines. Authorized under FDA PMA (P970053), it adheres to regulatory standards for excimer laser systems used in refractive corneal surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P970053 | Class III | Active |
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Manufacturer
- Manufacturer
- Nidek Co., Ltd.
Sources (1)
- FDA PMA P970053 24 fields · synced Sep 18, 2026