Bausch & Lomb Keracor 116 Excimer Laser System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM FDA PMA
- Generic Name
- Excimer laser system FDA PMA
Identifiers
- PMA Number
- P970056 FDA PMA
- FDA Product Code
- LZS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
The Keracor 116 Excimer Laser System is an ophthalmic excimer laser device designed for photorefractive keratectomy (PRK). It is classified as a Class III medical device and employs ultraviolet laser technology to reshape the cornea, correcting myopia (nearsightedness) within specified refractive ranges. The system is intended for use in patients aged 18 and older with stable refractive error, as defined by regulatory criteria. Its primary function is to ablate corneal tissue to achieve predictable vision correction outcomes.
This device is supplied as a complete ophthalmic laser system and is intended for use in sterile operating environments by trained ophthalmic surgeons. It is not single-use; the system requires proper maintenance and calibration to ensure accuracy and safety. The Keracor 116 operates under FDA approval (PMA P970056) and adheres to regulatory standards for laser safety, including compliance with 21 CFR 1040/10 and 1040.11. Storage and handling must follow manufacturer guidelines to preserve functionality and sterility of associated consumables. No MRI safety information is specified for this device.
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. Sources consulted: Bausch + Lomb Official Home Page, BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM (P970056) — FDA 510(k ..., PDF BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM PMA… - FDA.report, Bausch & Lomb – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P970056 | Class III | Active |
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Manufacturer
- Manufacturer
- Technolas GmbH Perfect Vision
Sources (1)
- FDA PMA P970056 24 fields · synced Sep 20, 2026