(72 days)
Not Found
No
The description focuses on the laser technology, wavelengths, energy levels, and basic control systems (microprocessor-based controller). There is no mention of AI, ML, image processing, or data-driven algorithms for diagnosis, treatment planning, or device control beyond standard operational parameters.
Yes.
The device is intended for the treatment of various medical conditions, including vascular lesions, pigmented lesions, and a range of benign pigment lesions, which are therapeutic applications.
No
The document describes the device's intended use for treatment (e.g., removal, ablation, vaporization) of various lesions and tissues, not for diagnosing conditions.
No
The device description clearly states it includes hardware components such as laser sources, an articulated arm, power supply, cooling system, and a microprocessor-based controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser system intended for treatment of various skin conditions and for soft tissue procedures. It directly interacts with the patient's body (in vivo) for therapeutic purposes.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
Therefore, the Q-Plus T Q-Switched laser falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Ruby (694nm)
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are
- Lentigines
- café-au-lait-blotches
- Ephalides
- Benign Naevi such as:
- Naevus of Ota
- Naevus of Ito
- Epidermal Naevi
- Congenital Naevi
- Beckers Naevi
- Blue Nevus
- Naevus Spillus
- Mongolian Spot
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The device includes a Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue lesions, vascular lesions, pigmented lesions, hair, tattoos.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General dermatology
Description of the training set, sample size, data source, and annotation protocol
None Performance Data
Description of the test set, sample size, data source, and annotation protocol
None Performance Data
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Quanta System O-Plus-T is as safe and effective as the predicate devices. The Q-Plus T has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness. Thus, the Q-Plus T is substantially equivalent.
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.
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
510(k) SUMMARY Quanta System Q-Plus T
| Submitter: | Quanta System SpA
via IV Novembre,116
21058 Solbiate
Olona VA / Italy |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Isabella Carrer
Medical Division Manager |
| Date Prepared: | June 28, 2007 |
| Device Trade Name: | Quanta System Q-Plus T |
| Common Name: | Laser surgical instrument for use in general surgery and
dermatology |
| Classification Name: | Instrument, surgical, powered, laser |
| Predicate Devices: | - Cynosure, Inc Affinity QS Q-Switched Nd:YAG
Laser System (K050382);
- ASCLEPION LASER TECHNOLOGIES GmbH
TattooStar R (K060787 ) |
| Intended Use /
Indications for Use: | Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for
treatment of vascular lesions, pigmented lesions, and
for hair, tattoo removal and the incision, excision,
ablation, vaporization of soft tissue for general
dermatology. |
| | Ruby (694nm) |
| | The Q-Plus T Q-Switched laser is intended for use for
cutting, vaporization and ablation of soft tissue and the
removal of tattoos and benign pigment lesion. |
| | Some examples of pigment lesions are |
| | Lentiginescafé-au-lait-blotches |
Title:
1
- 트 Ephalides
- Benign Naevi such as: 트
- Naevus of Ota .
- Naevus of Ito 8
- l Epidermal Naevi
- 포 Congenital Naevi
- l Beckers Naevi
- I Blue Nevus
- l Naevus Spillus
- I Mongolian Spot
Technological The device includes a Q-Switched Nd:YAG laser source Characteristics: with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece. None Performance Data
The Quanta System O-Plus-T is as safe and effective as Substantial the predicate devices. The Q-Plus T has the same Equivalence: intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness. Thus, the Q-Plus T is substantially equivalent.
2
Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with a human figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The image is simple and clean, with a focus on the department's emblem and name.
Food and Drug Administration 9200 Corporate Boulevard FEB 2 8 2008 Rockville MD 20850
Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
Re: K073549 Trade/Device Name: Q-Plus T 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: February 18, 2008 Received: February 19, 2008
Dear Mr. Job:
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. Ilsting 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
3
Page 2 - Mr. Mark Job
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.
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 M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Q-Plus T Device Name:
Indications for Use:
Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Ruby (694nm)
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are
- 트 Lentigines
- café-au-lait-blotches 에
- Ephalides 트
- l Benign Naevi such as:
- Naevus of Ota 트
- Naevus of Ito ■
- l Epidermal Naevi
- . Congenital Naevi
- Beckers Naevi 트
- 트 Blue Nevus
- Naevus Spillus I
- I Mongolian Spot
Prescription Use __X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
Mark A. Millman
(PLEASE DO NOT WRITE BELOW THIS LINE --IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (C
510(k) Number K0739