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photocoagulation of ocular tissue. The Oculight SLx is intended to be used to perform retinal photocoagulation as well as anterior segment procedures. The Keeler Microlase SL is intended for use in ophthalmic photocoagulation and is specifically indicated for use in the treatment of glaucoma and all retinal vascular diseases. The Nidek DC3000 is promoted as an ophthalmic photocoagulator. The Ceralas D2 and its predicates are all intended for the photocoagulation of ocular tissue which includes the retina as well as the anterior segment.

The Ceralas D2 is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide ("GaAlAs") semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode and cooling module containing the laser diode; (2) an optics module containing a beamsplitter pickoff for automatic control of total optical power; (3) front control and display panels; and (4) RFI-shielded, transformer isolated power supplies and control electronics. A fiber optic delivery system is coupled to the laser via an SMA-905 connector to deliver laser radiation to the target tissues. The fiber optic delivery system available with the Ceralas D2 consists of fibers with 200 um diameters. The Ceralas D2, like the predicate devices, is a microprocessor controlled, solid state laser that can be operated with slit lamps, indirect ophthalmoscopes, and endocular probes. The lasers all use diodes to create a laser treatment beam. The Ceralas D2 emits a beam between 780 and 840 nm, nominally at 810 nm; the Keeler Microlase SL emits light between 780 and 840 nm; and the Oculight SLx emits light nominally around 810 nm. The Ceralas D2, the Oculight SLx, and the Nidek DC3000 all have maximum laser treatment beam powers of 2 watts. The laser treatment beam emitted by the Ceralas D2 and the predicates can be delivered continuously or in pulses. The Ceralas D2's pulse can be varied from 0.1 to 99.9 seconds, i.e., to an effectively continuous delivery mode. The Oculight SLx has pulses of up to a 9 second duration. The pulse duration for the Keeler Microlase SL ranges between 0.01 and 1 second.

The provided text describes a medical device, the Ceralas D2 Diode Laser System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, sample sizes, or expert adjudication as requested in the prompt.

The document focuses on:

• Device Identification: Name, sponsor, contact info.
• Classification: Ophthalmic laser.
• Intended Use: Photocoagulation of ocular tissue.
• Predicate Devices: Iris Medical Oculight SLx, Keeler Microlase SL, Nidek DC3000.
• Technological Characteristics: Describes the Ceralas D2's components, laser type (GaAlAs semiconductor diodes), wavelength (780-840 nm, nominally 810 nm), maximum power (2 watts), and pulse duration.
• Substantial Equivalence Argument: Explains why the Ceralas D2 is substantially equivalent to the predicates based on intended use, principles of operation, and technological characteristics, highlighting similarities in microprocessor control, solid-state laser technology, and compatibility with delivery systems. It also addresses differences in pulse duration, arguing they do not raise new safety or effectiveness concerns.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, device performance, sample sizes, ground truth details, or information about MRMC or standalone studies based solely on the provided text. The document is a 510(k) submission summary, which typically focuses on demonstrating equivalence to legally marketed predicate devices rather than presenting detailed clinical study results with acceptance criteria.

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