(46 days)
The SpectraQuattro™ Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro™ Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.
SpectraQuattro™ comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended:
| Light Spectrum Filter | Indications |
|---|---|
| 410-1200 | Mild to moderate inflammatory and pustular inflammatory acnevulgaris |
| 530-1200 | pigmented lesions |
| 560-1200 | lentigenes |
| 585-1200 | Vascular lesions,rosacea, hemangiomas, leg veins |
| 640-1200 | Hair removal |
The SpectraQuattro Pulsed Light System is intended to provide phototherapeutic light to the body. The SpectraQuattro is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console which houses the power supply, cooling system, handpiece that contains the light source, and footswitch.
This document is a 510(k) premarket notification for the SpectraQuattro Pulsed Light System. It asserts substantial equivalence to predicate devices and does not contain detailed acceptance criteria or a study demonstrating device performance against specific metrics. Therefore, it is not possible to fill out the table and answer all questions as requested.
However, based on the provided text, here's what can be gathered regarding the device and its claims:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or report specific performance metrics for the SpectraQuattro Pulsed Light System beyond its general intended use and indications. The basis for clearance is substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
No test set or clinical data is presented in this 510(k) summary. The submission is based on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring ground truth establishment is described.
4. Adjudication method for the test set
Not applicable. No test set is described.
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 pulsed light system, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established for performance testing within this document.
8. The sample size for the training set
Not applicable. As a pulsed light system, it does not involve a training set as a machine learning model would.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Approval Process from the Document:
- Device Name: SpectraQuattro Pulsed Light System
- Intended Use: Generally indicated to treat dermatological conditions. Specifically indicated for: vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.
- Approval Basis: Substantial equivalence to legally marketed predicate devices, including Radiancy, Inc. SkinStation™ Pulsed Light System, Palomar Estelux™ Pulsed Light System, and CoolTouch, Inc. PRIMA Pulsed Light Therapy System.
- Key Argument for Equivalence: The SpectraQuattro has the same intended use, similar indications for use, the same principles of operation, and similar technological characteristics to the predicate devices. Minor differences are stated not to raise new issues in terms of performance, safety, or efficacy.
- Regulatory Classification: Class II, product code GEX (Laser surgical instrument for use in general and plastic surgery and in dermatology).
- Date Prepared: August 17, 2005
- FDA Decision Date: October 1, 2005 (Letter date)
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0C1 1 1 2005
510(k) Summary
AMJET Distributing, LLC SPECTRAQUATTRO PULSED LIGHT SYSTEM 510(k) Premarket Notification
| Submitter: | AMJET Distributing, LLC |
|---|---|
| Address: | 1025 Berkshire RoadMinneapolis, MN 55437 |
| Contact Person: | Stephen Trinter |
| Telephone: | 612-812-1636 |
| Facsimile: | 651-702-4411 |
| Date Prepared: | August 17, 2005 |
| Device Trade Name: | SpectraQuattro Pulsed Light System |
| Common Name: | Pulsed Light System |
| Classification Name: | Instrument, Surgical, Powered. Laser79-GEX, 21 CFR 878.4810 |
| Legally Marketed PredicateDevices: | Radiancy, Inc. SkinStation™ Pulsed Light System(K030897, K032205. K051268). Palomar Estelux™Pulsed Light System (K020453), CoolTouch, Inc.PRIMA Pulsed Light Therapy System (K041323). |
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| Description of the SpectraQuattroPulsed Light System: | The SpectraQuattro Pulsed Light System is intendedto provide phototherapeutic light to the body. TheSpectraQuattro is a compact, self-contained systemthat delivers a beam of pulsed light at wavelengthsof 300nm to 1400nm, which can be optimized atvarious wavelength ranges and delivered to thetreatment site. The system consists of a controlconsole which houses the power supply, coolingsystem, handpiece that contains the light source,and footswitch. |
|---|---|
| Intended Use of theSpectraQuattro Pulsed LightSystem: | The SpectraQuattro Pulsed Light System isgenerally indicated to treat dermatologicalconditions. The SpectraQuattro is specificallyindicated for the treatment of vascular lesions,rosacea, hemangiomas, leg veins, hair removal,pigmented lesions, lentigenes, and mild to moderateinflammatory and pustular inflammatory acnevulgaris. |
| Technological CharacteristicsAnd Substantial Equivalence: | The SpectraQuattro is a pulsed light systemgenerally indicated for the treatment ofdermatological conditions and the specific treatmentof vascular lesions, rosacea, hemangiomas, legveins, hair removal, pigmented lesions, lentigenes,and mild to moderate inflammatory and pustularinflammatory acne vulgaris. SpectraQuattro issubstantially equivalent to the Cooltouch PRIMA,and has the same intended use, the same principlesof operation and is technologically similar to theCooltouch PRIMA, with only minor exceptionswhich do not raise issues in terms of performance,safety or effectiveness. Additionally,SpectraQuattro has the same intended use, similarindications for use the same principles of operation |
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and similar technological characteristics as the Radiancy SkinStation and Palomar Estelux. SpectraQuattro is substantially equivalent to said predicate devices and minor differences between SpectraQuattro and these two systems does not raise any new issues in terms of performance, safety and efficacy.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
OCT 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amjet Distribution, LLC c/o Ned Devine Responsible Third Pary Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K052336 Trade/Device Name: SpectraQuattro™ Pulsed Light System 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: September 23, 2005 Received: September 26, 2005
Dear Mr. Devine:
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- Ned Devine
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Signature
رم Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052336
Device Name: SpectraQuattro™ Pulsed Light System
Indications for Use:
The SpectraQuattro™ Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro™ Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.
SpectraQuattro™ comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended:
| Light Spectrum Filter | Indications |
|---|---|
| 410-1200 | Mild to moderate inflammatory and pustular inflammatory acnevulgaris |
| 530-1200 | pigmented lesions |
| 560-1200 | lentigenes |
| 585-1200 | Vascular lesions,rosacea, hemangiomas, leg veins |
| 640-1200 | Hair removal |
| Prescription Use: | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
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Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_105233 ما3
§ 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.