(139 days)
Not Found
No
The document describes a laser device for various dermatological procedures. There is no mention of AI or ML in the intended use, device description, or any of the provided sections. The technology described is a standard laser system.
Yes
Explanation: The device is indicated for various medical treatments such as incision, excision, ablation, vaporization of soft tissue, tattoo removal, treatment of pigmented and vascular lesions, skin resurfacing, and hair removal, all of which are considered therapeutic applications.
No
The document describes the Light Age Q-Clear™ Laser for various treatment applications like incision, excision, ablation, vaporization, tattoo removal, and treatment of skin lesions and vascular lesions. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description clearly describes a laser system with hardware components (Nd:YAG crystal rod, handpiece, aiming beam) for delivering energy to tissue, not a software-only device.
Based on the provided information, the Light Age Q-Clear™ Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Light Age Q-Clear™ Laser is a therapeutic device that uses laser energy to directly treat soft tissue and skin conditions. It is applied externally to the patient's body.
- Intended Use: The stated intended uses are for incision, excision, ablation, vaporization, and removal/treatment of various skin and tissue conditions. These are all direct therapeutic interventions, not diagnostic tests performed on samples outside the body.
- Device Description: The description details the laser technology and its delivery to the target area on the skin. There is no mention of analyzing biological samples.
Therefore, the Light Age Q-Clear™ Laser falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Light Age Q-Clear™ Laser is intended for the following uses:
-
- For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
-
- The 1064nm wavelength is indicated for:
- Dark ink tattoo removal -
- Treatment of pigmented lesions (particularly Nevus of Ota) -
- Removal or lightening of hair -
- Skin resurfacing with or without adjuvant preparation :
- Treatment of common nevi --
-
- The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos ー
- Treatment of common nevi -
- Treatment of café-au-lait spots --
- Treatment of seborrheic kcratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, : angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
Product codes
GEX
Device Description
The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The 532nm emission is the optional frequency could mithe lascr is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K023967, K022709, K983054, K011677, K014234, K000317
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 2 5 2004
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string begins with a capital letter 'K', followed by the numbers '033259'. The numbers are written in a slightly irregular style, with some variations in size and spacing.
LIGHT AGE, INC.
510(k) Summary of Safety and Effectiveness Light Age Q-Clear™ Laser
In accordance with the Safe Medical Devices Act of 1990, 21CFR 807.92, the Following is a In accordance with the Sale Medical Devises information on which the substantial equivalence determination is based.
The safety and effectiveness of the Light Age Q-Clear™ Laser derives from a The safety and crecerveness of the predicate to the predicate devices listed below.
Light Age, Inc. Applicant: 500 Apgar Dr. Somerset, NJ 08873 Thomas C. Hauck, Manager of Quality and Process Technology
Date Prepared: December 24, 2003
Model:
Trade Name: Light Age Q-Clear™ Laser Hade Name: "Digit Aigh Nd:YAG Laser with Frequency Doubler
Product Code: GEX
Panel: 79
C.F.R. Section: 878.4810
Classification Panel: Gencral & Plastic Surgery
Classification:
Medical Device Class: Regulatory Class II
Laser Safety Class: Class IV Laser Product
Predicate Devices:
- Palomar Q-Y AG™ Nd:YAG Laser System (K023967) -
- Medlite™ Q-Switched Nd:YAG Laser (K022709 & K983054) -
- Mcdlite™ C3 Q-Switched Nd:YAG Laser (K011677) -
- Medlite™ C6 Q-Switched Nd:YAG Laser (K014234) -
- Spectra-VRM Q-Switched Nd:YAG Laser System (K000317) -
Description:
The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed
1
LIGHT AGE, INC.
energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The 532nm emission is the optional frequency could mithe lascr is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.
Intended Use:
The Light Age Q-Clear™ Laser is intended for the following uses:
-
- For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
-
- The 1064nm wavelength is indicated for:
- Dark ink tattoo removal -
- Treatment of pigmented lesions (particularly Nevus of Ota) -
- Removal or lightening of hair -
- Skin resurfacing with or without adjuvant preparation :
- Treatment of common nevi --
-
- The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos ー
- Treatment of common nevi -
- Treatment of café-au-lait spots --
- Treatment of seborrheic kcratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, : angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
Safety and Effectiveness:
The Light Age Q-Clear™ Laser has the same wavelengths, the same spot size, the same Frie Light of operation, essentially the same fluence levels, and the same intended use as the predicate devices. The Light Age Q-Clear™ Laser does not raise new questions of safety or efficacy, and is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
FEB 2 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas C. Hauck Manager of Quality and Process Technology Light Age, Inc. 500 Apgar Drive Somerset, New Jersey 08873
Re: K033259 Trade/Device Name: Light Agc Q-Clear™ Laser 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: January 20, 2004 Received: January 20, 2004
Dear Mr. Hauck:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave decemblied by marketed predicate devices marketed in interstate for use stated in the cherosure) to regary to regars and the Medical Device American son to any for at Free d. Fored. Four commerce province to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been reculssined in assess approval of a premarket approval application (PMA). and Costiere Act (Act) that do not requent sppto the general controls provisions of the Act. The You may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the Procession, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aboro) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of roants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a baseas.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or ally recetal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set as the treat CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Thomas C. Hauck
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manceing your and equivalence of your device to a legally prematication. The PDF mailing of mailing of mailing of 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), plcase If you desire specific advice for Jour ac 1) 594-4659. Also, please note the regulation entitled, Colliact the Office of Compilance in the notification" (21CFR Part 807.97). You may obtain Misolanding by reference to promation on the Act from the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-frec number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
h Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
LIGHT AGE, INC.
Indications for Use
510(k) Number (if known): K033259
Device Name: Light Age Q-Clear™ Laser
Indications for Use:
The Light Age Q-Clear™ Laser is indicated for the following uses:
-
- For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
-
- The 1064nm wavelength is indicated for:
- Dark ink tattoo removal ।
- Removal of pigmented Icsions (particularly Nevus of Ota) ..
- Removal or lightening of hair =
- Skin resurfacing with or without adjuvant preparation ー
- Treatment of common nevi --
-
- The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos -
- Treatment of common nevi |
- Treatment of café-au-lait spots -
- Treatment of seborrheic keratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 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 |
| (Posted November 13, 2003) | Page 1 of 1 |
|---|---|
| ---------------------------- | ------------- |
| 510(k) Number | K033259 |
|---|---|
| --------------- | --------- |
510(k)-Notification-Q-Clear-additional-info-2004-01-23b.doc