(150 days)
The PhotoNova Family of Pulsed Light Systems is indicated for the following:
• The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction
• The treatment of benign pigmented lesions, including lentigines, nevi, melasma and café-au-lait
• The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins
• Treatment of inflammatory acne (acne vulgaris)
The Photonova Pulsed Light Systems delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
The provided document is a 510(k) summary for the PhotoNova Family of Pulsed Light Systems. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not include specific performance data or details about a study designed to prove the device meets acceptance criteria.
The document states: "The PhotoNova Family of Pulsed Light Systems is substantially equivalent to other existing pulsed light systems in commercial distribution in Dermatology and Plastic Surgery." This implies that the acceptance criteria are met by demonstrating equivalence to devices already on the market, rather than through novel performance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the PhotoNova Family of Pulsed Light Systems. The primary "performance" reported is its substantial equivalence to predicate devices, which implies it performs comparably for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative criteria for this device. Implied acceptance is based on substantial equivalence to predicate devices, meaning it is expected to perform comparably for the given indications. | "The PhotoNova Family of Pulsed Light Systems is substantially equivalent to other existing pulsed light systems in commercial distribution in Dermatology and Plastic Surgery." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not available in the provided text.
- Data provenance: Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available in the provided text. The document refers to predicate devices, implying similarity in function and safety, rather than a new study with expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/available as there is no mention of a specific test set or adjudication process for this device's performance.
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:
- No. This is a pulsed light system, not an AI-assisted diagnostic device. Therefore, an MRMC study with human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (pulsed light system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/available for a new study. The basis for acceptance is substantial equivalence to legally marketed predicate devices. The "ground truth" for the predicate devices would have been established via their own clinical data and regulatory approvals, which are not detailed here.
8. The sample size for the training set:
- Not applicable/available. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/available. As above, this device does not utilize a training set in the AI sense.
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510(K) Summary
PhotoNova Family of Pulsed Light Systems
K073477
This 510(K) Summary of safety and effectiveness for the Photonova Family of Pulsed Light Systems is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Photonova of Sweden AB | |
|---|---|---|
| Address: | Hulda Lindgrens Gata 6C42131 Vastra FrolundaSWEDEN | |
| Contact Person: | Anders Bonde | |
| Telephone / Fax / Email | 46-31-742-1281- Phoneabonde@photonova.com | |
| Preparation Date: | October 31, 2007 | |
| Device Trade Name: | Photonova Family of Pulsed Light Systems | |
| Common Name: | Intense Pulsed Light | |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | OmniLight K032191Lux V K040081StarLux K03349 | |
| Description of the Photonova Family ofPulsed Light Systems | The Photonova Pulsed Light Systems delivers pulsed light atwavelengths starting at 515 nanometers. The device consistsof three interconnected sections: The cabinet which housesthe power supply, the cooling system and the microcontroller,the umbilical to the handpiece, and the handpiece, whichhouses the waveguide | |
| Intended use of the Photonova Family ofPulsed Light Systems | The Photonova Pulsed Light System is indicated for thefollowing:• The removal of unwanted hair form all skin types andto effect stable long-term or permanent hairreduction• The treatment of benign pigmented lesions, includinglentigines, nevi, melasma and café-au-lait• The treatment of vascular lesions, including port winestains, hemangiomas, angiomas, ttelangiectasias,rosacea, facial and leg veins• Treatment of inflammatory acne (acne vulgaris) |
Performance Data:
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510(K) Summary PhotoNova Family of Pulsed Light Systems
Conclusion:
The PhotoNova Family of Pulsed Light Systems is substantially equivalent to other existing pulsed light systems in commercial distribution in Dermatology and Plastic Surgery.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2008
Photonova of Sweden AB % Ms. Connie Hoy 908 Stetson Street Woodland, California 95776
Re: K073477
Trade/Device Name: PhotoNova Family of Pulsed Light Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 30, 2008 Received: May 5, 2008
Dear Ms. Hoy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Connie Hoy
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 4 Indications For Use Statement
510(k) Number (if Known):
Device Name: PhotoNova Family of Pulsed Light Systems
Indications for Use:
Prescrip
The PhotoNova Family of Pulsed Light Systems is designed for use in dermatology applications including:
- · The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction
- · The treatment of benign pigmented lesions, including lentigines, nevi, melasma and caféau-lait
- · The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins
- · Treatment of inflammatory acne (acne vulgaris)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Nih for mem
Concurrence of EURH Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K023477 |
|---|---|
| --------------- | --------- |
| ption Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ----------- | --- | ---- | ---------------------- |
§ 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.