Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser Syste…
FDA 510(k)Class II (US FDA 510(k))
by Lumenis Inc.
Identifiers
- 510(k) Number
- K973470 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Coherent Popeye Ophthalmic Laser System is a laser device designed for ophthalmic procedures. It delivers laser energy for photodisruption of ocular tissue, including posterior capsulotomy and pupillary membranectomy in aphakic and pseudophakic patients. The system operates using a Nd:YAG laser, enabling precise tissue dissection in surgical settings. When used in combination with an Argon laser, it extends its application to argon laser photocoagulation for ocular pathology treatment.
This device is intended for use in clinical ophthalmic settings and is supplied as a reusable medical instrument. It requires proper sterilization and maintenance per manufacturer guidelines. The system is classified under FDA product code GEX and holds a 510(k) clearance for substantial equivalence. No additional regulatory markings or sterility assurances are specified in the provided data.
Frequently asked questions
What procedures is the Popeye Ophthalmic Laser System designed for?
The Popeye Ophthalmic Laser System is specifically designed for photodisruption of ocular tissue, including posterior capsulotomy (removal of the posterior lens capsule) and pupillary membranectomy (removal of pupillary membranes) in patients who are aphakic (without a lens) or pseudophakic (with an artificial lens). It also enables argon laser photocoagulation when used in combination with the Coherent Argon laser, which is used to treat various ocular pathologies.
How is the Popeye Ophthalmic Laser System supplied and maintained?
The Popeye Ophthalmic Laser System is supplied as a reusable medical instrument. It requires proper sterilization and regular maintenance as outlined in the manufacturer’s guidelines to ensure safe and effective operation. Sterilization protocols must be followed to prevent cross-contamination between procedures.
Is the Popeye Ophthalmic Laser System single-use or reusable?
The Popeye Ophthalmic Laser System is designed for reuse. However, it must undergo thorough sterilization between uses to maintain safety and functionality. The manufacturer provides specific instructions for cleaning, disinfection, and maintenance to ensure the device remains operational for multiple procedures.
What regulatory clearance does the Popeye Ophthalmic Laser System hold?
The Popeye Ophthalmic Laser System holds a 510(k) clearance from the FDA, indicating it is substantially equivalent to a legally marketed device. This clearance was granted under product code GEX and was reviewed by the FDA’s General and Plastic Surgery Advisory Committee in 1997. The device is not explicitly marked as sterile.
Can the Popeye Ophthalmic Laser System be used with other lasers?
Yes, the Popeye Ophthalmic Laser System can be used in combination with the Coherent Argon laser. This pairing extends its functionality to include argon laser photocoagulation, which is useful for treating certain ocular pathologies beyond the Nd:YAG laser’s primary applications.
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: Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic ..., Global Leader in Materials, Networking, and Lasers | Coherent, PDF aqmc342 - Food and Drug Administration, Coherent (Unternehmen) – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K973470 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Inc.
Sources (1)
- FDA 510(k) K973470 24 fields · synced Oct 1, 2026