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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

Device Description

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) indicate that no clinical performance study was conducted to prove the device meets acceptance criteria. The summary explicitly states:

"7.2 Summary of Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the following information cannot be extracted from the provided document as it pertains to clinical performance which was not performed or deemed necessary for this 510(k) clearance.

A table of acceptance criteria and the reported device performance (for clinical performance)
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method
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 (This is typically for AI/imaging devices, not a light therapy wand)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for this device type)
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

However, based on the non-clinical tests performed, we can infer the acceptance criteria for those tests and their reported performance:

Non-Clinical Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Electrical Safety & EMC	IEC 60601-1 (Ed. 3.2)	Compliance with standard for general requirements for basic safety and essential performance.	Compliant with standard.
	IEC 60601-1-11 (Ed. 2.1)	Compliance with standard for home healthcare environment.	Compliant with standard.
	IEC 60601-2-57 (Ed. 1.0)	Compliance with standard for non-laser light source equipment for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use.	Compliant with standard.
	IEC 60601-1-2 (Ed. 4.1)	Compliance with standard for electromagnetic disturbances.	Compliant with standard.
Photobiological Safety	IEC 62471 (Ed. 1.0)	Compliance with standard for photobiological safety of lamps and lamp systems.	Compliant with standard.
Battery Safety	IEC 62133-2 (Ed. 1.0)	Compliance with standard for safety requirements for portable sealed secondary cells, for use in portable applications – Lithium systems.	Compliant with standard.
Biocompatibility	ISO 10993-5	Compliance with standard for cytotoxicity.	Complies (based on material equivalence to previously cleared devices).
	ISO 10993-10	Compliance with standard for sensitization.	Complies (based on material equivalence to previously cleared devices).
	ISO 10993-10	Compliance with standard for irritation.	Complies (based on material equivalence to previously cleared devices).
Software	FDA Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions"	Documentation (Basic Documentation Level) for appropriate verification and validation.	Software verification and validation conducted and documentation provided.
Usability	N/A (Standard not specified)	Usability requirements for safe and effective use.	Usability testing conducted.

Additional Information Not Applicable/Provided:

Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed. For non-clinical tests, these metrics are not typically reported in this format.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
Adjudication method: Not applicable as no clinical study was performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is typically for AI/imaging devices.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is typically for AI/software devices.
The type of ground truth used: Not applicable as no clinical study was performed.
The sample size for the training set: Not applicable as no clinical study was performed.
How the ground truth for the training set was established: Not applicable as no clinical study was performed.

In summary, the KALA Therapy Wand (Model: KALA-03) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with relevant safety and performance standards, without the need for a separate clinical effectiveness study.

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