(90 days)
Not Found
No
The device description focuses on the laser technology and its components, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for the "treatment of vascular and pigmented skin lesions," which indicates a therapeutic purpose.
No
The device description clearly states its purpose is for "treatment of vascular and pigmented skin lesions" and describes it as a "semiconductor-based dermatology laser system," indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a hardware-based laser system with physical components like semiconductor lasers, optical fibers, and handpieces. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The treatment of vascular and pigmented skin lesions." This describes a therapeutic application directly on the patient's body.
- Device Description: The device is a laser system designed to deliver light energy for treatment. It uses a laser console and handpieces that are applied to the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimens.
The device is a therapeutic laser system used for dermatological procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
86 HOF, 79 GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K964074, K954905, K951034, K913569
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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