(90 days)
The OcuLight GL is currently cleared for retinal photocoagulation and laser trabeculoplasty using ophthalmic delivery devices (IRIS Slit Lamp Adapter, IRIS Laser Indirect Ophthalmoscope, IRIS EndoProbe). The Dermatology Handpiece will expand the intended use of this device for the treatment of vascular and pigmented skin lesions.
The OcuLight GL is a semiconductor-based dermatology laser system which delivers true continuous wave green laser light. For the additional indication in the treatment of vascular and pigmented lesions it will be used in conjunction with fiber optically coupled Dermatology Handpieces which have received prior FDA-premarket clearance (K964074).
The OcuLight GL is a semiconductor-based laser console which delivers green laser light. The OcuLight GL uses infrared (808 nm) semiconductor diode laser light as the primary source of optical energy which is then wavelength converted to a visible green (532 nm) laser light for the treatment delivery.
A second visible red (630-650 nm) semiconductor CW laser is used for aiming. The 532 nm treatment and 630-650 nm pilot/aiming beams are optically combined inside the laser head and therefore follow the same path. The treatment and aiming beams are coaxial (i.e. follow the same path) in the OcuLight GL. The aiming beam is turned on when the OcuLight is placed into Treat mode.
The delivery devices currently cleared for use with the OcuLight GL are the IRIS Slit Lamp Adapter (SLA), the IRIS EndoProbe, and the IRIS Laser Indirect Ophthalmoscope (LIO). Delivery devices not specifically intended for use with the OcuLight GL will not be recognized by the fiber interlock circuit as a valid delivery device.
For the new indications, the OcuLight GL will utilize the Dermatology Handpieces connected to the fiber port. As was true with the three previously FDA-cleared fiber optically coupled delivery devices used with the OcuLight GL, the distal end of the Dermatology Handpieces will be the laser aperture and not the fiber port on the laser console. The laser port is electronically interlocked so that no laser energy can be emitted without the correct connection of a recognized delivery device.
This 510(k) summary (K982031) describes the IRIS Medical Instruments, Inc. OcuLight GL With Dermatology Handpieces. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for its intended use in treating vascular and pigmented skin lesions.
The document primarily covers:
- Submitter and Device Information: Name, address, contact, date prepared, FDA registration, device name, and classification.
- Predicate Devices: A list of legally marketed laser systems to which the OcuLight GL is considered substantially equivalent.
- Intended Use: Expansion of the existing OcuLight GL's use to include vascular and pigmented skin lesion treatment with Dermatology Handpieces.
- Device Description: Explanation of the OcuLight GL's technology (semiconductor-based, green laser light, aiming beam) and how it works with the Dermatology Handpieces.
- Technological Characteristics and Substantial Equivalence: A comparison of the OcuLight GL's characteristics (wavelength, power, delivery devices, indications) to the predicate devices to support the claim of substantial equivalence.
- FDA Response Letter: Confirmation of substantial equivalence and market clearance.
Therefore, I cannot populate the requested table and answer the study-related questions from the provided text. The document is strictly a 510(k) submission summary for demonstrating substantial equivalence, not a report on performance studies against acceptance criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.