(130 days)
The ezlase™ diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
The ezlase™ diode laser system, was cleared for dental soft tissue indications under KQ61898 and K083069. The system uses a Gallium Aluminum Arsenide (GaAlA) and/or an Indium Gallium Arsenide Phosphorus (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiberoptic cable to a handpiece that emits the energy to the targeted site. A visible light is emitted at the same time to visually identify the treatment location.
This document, K083595, describes a Special 510(k) Summary Statement for the Biolase Technology, Inc. ezlase™ diode laser system. The purpose of this 510(k) is to expand the current indications for use to include therapeutic indications.
Acceptance Criteria and Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative performance metric table as might be found for a diagnostic device. Instead, the justification for the expanded indications relies on substantial equivalence to already cleared predicate devices. The "performance" being demonstrated is that the ezlase™ meets the same therapeutic claims as these predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device emits energy in the near-infrared spectrum to provide topical heating. | The ezlase™ diode system emits energy in the near-infrared spectrum to provide topical heating. |
| Device is for temporary relief of minor muscle and joint pain and stiffness. | Confirmed for temporary relief of minor muscle and joint pain and stiffness. |
| Device is for temporary relief of minor arthritis pain. | Confirmed for temporary relief of minor arthritis pain. |
| Device is for temporary relief of muscle spasm. | Confirmed for temporary relief of muscle spasm. |
| Device is for temporary relief of minor sprains and strains. | Confirmed for temporary relief of minor sprains and strains. |
| Device is for temporary relief of minor muscular back pain. | Confirmed for temporary relief of minor muscular back pain. |
| Device provides temporary increase in local blood circulation. | Confirmed for temporary increase in local blood circulation. |
| Device provides temporary relaxation of muscle. | Confirmed for temporary relaxation of muscle. |
| Equivalence to cleared predicate devices for therapeutic indications. | Determined substantially equivalent to K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module), and K082707 (MedX LPT200 and LPS200). |
Study Details:
This submission is a Special 510(k) for expanding indications based on substantial equivalence to existing cleared devices, not a clinical trial demonstrating novel performance against new, specific acceptance criteria through a newly conducted study. Therefore, many of the typical elements of a standalone clinical study are not applicable or explicitly provided in this document.
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Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a new clinical test set. The basis for approval is substantial equivalence to previously cleared devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no new clinical test set described in this document. The "ground truth" for the predicate devices would have been established during their respective clearances, but details are not provided here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system for therapeutic use, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The "performance" assessment is based on the functional and claims equivalence to predicate devices, not a standalone algorithm's performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of this 510(k) submission, the "ground truth" or evidence of effectiveness for the therapeutic indications is derived from the prior FDA clearance of the predicate devices with identical (or very similar) Indications for Use. This implicitly relies on the data and "ground truth" (likely clinical study outcomes or established physiological effects) that supported the original clearances of those predicate devices.
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The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.