The Photonica Professional ("Photonica") is a non-invasive red light system with a power output of 105mW/cm , consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm, for treatment of superficial, benign vascular and pigmented lesions. The components include a mobile pole cart, controller console which plugs into a hospitalgrade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), 20 minute timer, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. Treatment time is preset to 20 minutes via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm and standard energy dose of 126 J/cm . Photonica does not use any software.

AI/ML Overview

The provided document is a 510(k) Summary for the Photonica Professional device. It asserts substantial equivalence to a predicate device (Omnilux revive™) based on similarities in intended use and technological characteristics, and compliance with non-clinical performance standards. However, it explicitly states that no clinical testing was required or performed.

Therefore, based on the provided document, the Photonica Professional device does not have a study that proves it meets acceptance criteria in the way typically associated with clinical performance or effectiveness studies. The acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, relying on the predicate's established safety and effectiveness.

Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were performed for the Photonica Professional itself, there are no specific clinical "acceptance criteria" or "reported device performance" related to its efficacy in treating superficial, benign vascular, and pigmented lesions. The "acceptance criteria" for its market clearance are based on its substantial equivalence to the predicate device and compliance with non-clinical safety and performance standards.

The table below summarizes the comparison of characteristics to the predicate device, which forms the basis of the substantial equivalence claim, rather than a direct acceptance criteria for clinical performance.

Characteristic	Acceptance Criteria (Predicate's Performance or Standard Compliance)	Reported Device Performance (Photonica Professional)
Indications for Use	In dermatology for treatment of superficial, benign vascular, and pigmented lesions.	In dermatology for treatment of superficial, benign vascular, and pigmented lesions.
Wavelength	633±6nm (visible red light spectrum)	635nm± 2nm (visible red light spectrum)
Bandwidth	20nm + 3nm	10nm
Output intensity/Irradiance	105 mW/cm²	105 mW/cm²
Recommended Treatment Time	20 minutes	20 minutes
Standard Energy Dose	126 J/cm²	126 J/cm²
Photobiological Safety	Compliance with IEC 62471	Compliant with IEC 62471
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57 (implied by predicate, explicitly stated for new device)	Compliant with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57; performs according to specifications and functions as intended. Does not use any software.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set was used for the Photonica Professional device. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth was created or used for the Photonica Professional device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

5. 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 light therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have an "algorithm" in the sense of AI. It is a light therapy device. The document explicitly states: "Photonica does not use any software." Therefore, no standalone performance study of an algorithm was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No direct clinical ground truth for efficacy was established for the Photonica Professional, as no clinical studies were conducted for it. Its efficacy is inferred from the substantial equivalence to the predicate device, which presumably had its efficacy established through clinical data or historical use.

8. The sample size for the training set

Not applicable. This device does not use software or AI/ML, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for software/AI, no ground truth for a training set was established.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are connected to a wing-like shape above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2015

Ward Photonics LLC % Ms. Diane Sudduth Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K150336

Trade/Device Name: Photonica Professional Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 6, 2015 Received: February 10, 2015

Dear Ms. Sudduth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Photonica Professional

Indications for Use (Describe)

Photonica Professional is indicated for use in dermatology for the treatment of superticial, benign vascular, and pigmented lesions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary

K150336

For

Photonica Professional

1. Submission Sponsor

Ward Photonics LLC 1980 N. Atlantic Avenue Cocoa Beach, FL 32931 USA Phone: 1-800-392-5950 Fax: 1-800-392-5950 Contact: Terry Ward, Managing Director

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (512) 818.3811 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Audrey Swearingen, Senior Global Regulatory Consultant Email:_project.management@emergogroup.com

3. Date Prepared

January 6, 2015

4. Device Identification

Trade/Proprietary Name:	PHOTONICA PROFESSIONAL
Common/Usual Name:	Laser Powered Surgical Equipment
Classification Name:	Powered Laser Surgical Instrument
Classification Regulation:	878.4810
Product Code:	GEX
Device Class:	Class II
Classification Panel:	General & Plastic Surgery

5. Legally Marketed Predicate Device(s)

The Photonica Professional is substantially equivalent to the Omnilux revive™ manufactured by Photo Therapeutics Ltd and subject of K030426.

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6. Device Description

7. Indication for Use Statement

Photonica is intended for use in dermatology for treatment of superficial, benign vascular and pigmented lesions.

8. Substantial Equivalence Discussion

The intended use and technological characteristics of this device are identical to the predicate device. The principles of operation and base elements of the device are similar to the predicate device and do not raise different questions of safety and effectiveness than the predicate. See Section 12 – Substantial Equivalence Discussion.

Manufacturer	Photo Therapeutics Ltd	Ward Photonics, LLC	Significant
Trade Name	PredicateOmnliux revive™	New DevicePhotonica Professional	Differences
510(k) Number	K030426	Not assigned	N/A
Product code	GEX	GEX	N/A
RegulationNumber	878.4810	878.4810	N/A
Clinical / Design Features
Indications forUse	In dermatology fortreatment of superficial,benign vascular, andpigmented lesions.	In dermatology for treatmentof superficial, benignvascular, and pigmentedlesions.	None
GeneralDesign Feature	One LED array	One LED array	None
Adjustable LEDPanel?	Y	Y – articulated arm allows formany adjustments.	None
Non-invasive?	Y	Y	None

		Table 5A - Comparison of Characteristics
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Manufacturer	Photo Therapeutics Ltd	Ward Photonics, LLC	Significant
Trade Name	PredicateOmnliux revive™	New DevicePhotonica Professional	Differences
ProtectiveEyewearIncluded?	Y - one pair for the patient	Y - one pair for the patient;one pair for the operator	Photonica providesoperator eyewear foradded safety
		Head / Lamp Specifications
Wavelength	633±6nm (visible red lightspectrum)	635nm± 2nm (visible redlight spectrum)	Similar, + variance is inalignment with the rangeof both devices
Bandwidth	20nm + 3nm	10nm	Photonica has a narrowerspecification than thepredicate
Total LEDPower Output	44.7 W + 5W	240 W	Photonica has more totalpower, but power isdistributed over a largerarea such that the outputinternally and dosage isthe same as Omnilux.
Outputintensity/Irradiance(mW/cm²)	105 mW/cm²	105 mW/cm²	None
RecommendedTreatmentTime(minutes)	20 minutes	20 minute	None
StandardEnergy Does(J/cm²)	126 J/cm²	126 J/cm²	None
TypicalCoverage Area(cm²)	803 cm²	2294 cm²	Similar, spot size isdependent upon numberof LEDs and arrayconfiguration.
Head / LampDimensions(cm)	32 cm x 28 cm	28.8 cm x 44.5 cm	No functional difference
Dimensions ofActive LEDArea (cm)	15 cm x 28 cm	22 cm x 38 cm	No functional difference
Overall Device Specifications
UnitDimensions (Hx W x D)	35.5 cm x 17.8 cm x 48 cm	183.2 cm x 62.2 cm x 61 cm	Omnilux is a tabletopdevice; the Photonica is afree standing unit on amobile cart.
Weight (kg)	12 kg	52 kg (with carton)	Photonica includes safetybenefit of the isolationtransformer whichweighs 7.7 kg; size of thePhotonica device is largerthan the Omnilux.
Manufacturer	Photo Therapeutics Ltd	Ward Photonics, LLC	Significant
Trade Name	PredicateOmnliux revive™	New DevicePhotonica Professional	Differences
Electrical Base	120 VAC, 8.0 amps, 50/60Hz	100-120 VAC, 3 amps, 50/60Hz	Functionally the same
Power source	90V -250V, 8A, 50/60 Hz	100-120 VAC, 3A, 50/60 Hz	Functionally the same
OperatingTemperature	10°C to 30°C	+5°C to 35°C	Similar, both comply withIEC 60601-1 safety
OperatingHumidity	30% to 85% (Relative)	10% to 90% RH, non-condensing	standard which includesoperating temperaturesand humidity; bothdevices are intended foruse in the sameenvironmentalconditions.
CoolingMechanism	Forced air ventilation	Forced air ventilation	None
Safetyfeatures	Unknown	Isolation transformerseparates facility power fromthe device. Power switchcancels the treatment(lowest risk; key switch notrequired by IEC standards).	Not available forcomparison

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness, Photonica was tested and shown to be in compliance with IEC 62471 for Photobiological Safety of Lamps and Lamp Systems. Testing to the third edition of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57 has been conducted and demonstrated that the Photonica device performs according to specifications and functions as intended.

Based upon an analysis of the overall performance characteristics for the device, Ward Photonics (hereafter "Ward") believes that Photonica Professional is substantially equivalent to the predicate device. In addition, Ward concludes that the Photonica is substantially equivalent with respect to safety, effectiveness and functionality to the Omnilux revive with the exception of the Photonica does not contain software.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.

11. Statement of Substantial Equivalence

The Photonica device has the same intended use and technological characteristics as the predicate device, Omnilux revive™, manufactured by Photo Therapeutics Ltd.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for its intended use.

Regulation Number and Section

§ 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.