K Number
K052336
Device Name
SPECTRAQUATTRO PULSED LIGHT SYSTEM
Date Cleared
2005-10-11

(46 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 acne<br>vulgaris | | 530-1200 | pigmented lesions | | 560-1200 | lentigenes | | 585-1200 | Vascular lesions,rosacea, hemangiomas, leg veins | | 640-1200 | Hair removal |
Device Description
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.
More Information

Not Found

No
The summary describes a pulsed light system with different filters for various dermatological conditions. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.

Yes
The device is indicated for the treatment of various dermatological conditions, including vascular lesions, rosacea, acne, and hair removal, which are all therapeutic applications.

No

The device is indicated for treatment of dermatological conditions (e.g., vascular lesions, rosacea, hair removal, etc.) and provides phototherapeutic light; it does not mention making a diagnosis.

No

The device description explicitly states that the system consists of a control console, power supply, cooling system, handpiece, and footswitch, which are all hardware components.

Based on the provided information, the SpectraQuattro™ Pulsed Light System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states that the device is used to "treat dermatological conditions" and "provide phototherapeutic light to the body." This involves applying light energy directly to the patient's body for therapeutic purposes.
  • Device Description: The description details a system that delivers pulsed light to a treatment site on the body.
  • Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The SpectraQuattro™ does not perform any analysis on specimens.

The SpectraQuattro™ is a therapeutic device that uses light energy for treatment, not a diagnostic device that analyzes samples.

N/A

Intended Use / 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 FilterIndications
410-1200Mild to moderate inflammatory and pustular inflammatory acne vulgaris
530-1200pigmented lesions
560-1200lentigenes
585-1200Vascular lesions, rosacea, hemangiomas, leg veins
640-1200Hair removal

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030897, K032205, K051268, K020453, K041323

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

0C1 1 1 2005

K052336

510(k) Summary

AMJET Distributing, LLC SPECTRAQUATTRO PULSED LIGHT SYSTEM 510(k) Premarket Notification

Submitter:AMJET Distributing, LLC
Address:1025 Berkshire Road
Minneapolis, 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. Laser
79-GEX, 21 CFR 878.4810
Legally Marketed Predicate
Devices:Radiancy, Inc. SkinStation™ Pulsed Light System
(K030897, K032205. K051268). Palomar Estelux™
Pulsed Light System (K020453), CoolTouch, Inc.
PRIMA Pulsed Light Therapy System (K041323).

1

| Description of the SpectraQuattro
Pulsed Light System: | 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. |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the
SpectraQuattro Pulsed Light
System: | The SpectraQuattro Pulsed Light System is
generally indicated to treat dermatological
conditions. The SpectraQuattro 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. |
| Technological Characteristics
And Substantial Equivalence: | The SpectraQuattro is a pulsed light system
generally indicated for the treatment of
dermatological conditions and the specific treatment
of vascular lesions, rosacea, hemangiomas, leg
veins, hair removal, pigmented lesions, lentigenes,
and mild to moderate inflammatory and pustular
inflammatory acne vulgaris. SpectraQuattro is
substantially equivalent to the Cooltouch PRIMA,
and has the same intended use, the same principles
of operation and is technologically similar to the
Cooltouch PRIMA, with only minor exceptions
which do not raise issues in terms of performance,
safety or effectiveness. Additionally,
SpectraQuattro has the same intended use, similar
indications for use the same principles of operation |

2

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.

3

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.

4

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 FilterIndications
410-1200Mild to moderate inflammatory and pustular inflammatory acne
vulgaris
530-1200pigmented lesions
560-1200lentigenes
585-1200Vascular lesions,rosacea, hemangiomas, leg veins
640-1200Hair removal
Prescription Use:X
(Part 21 CFR 801 Subpart D)

AND/OR

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

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_105233 ما3