(59 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on laser and light handpieces for various dermatological and surgical procedures.
Yes
The device is described as treating various medical conditions and performing surgical applications, which falls under the definition of a therapeutic device.
No
The device is described as being for "coagulation," "skin resurfacing," "treatment," "excision," "incision," "ablation," and "vaporization" of soft tissue and various lesions, which are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description explicitly states that the system consists of a console with internal hardware components (power supply, chiller, electronics) and handpieces that connect to the console. This indicates a physical hardware device, not a software-only device.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The description clearly states the device is a system with light and laser handpieces intended for procedures performed directly on the patient's body, such as coagulation, resurfacing, excision, incision, ablation, and vaporization of soft tissue.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to interact with the tissue directly.
Therefore, the Artisan Aesthetic System, as described, falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG, ONF
Device Description
The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands.
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)
The review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Artisan Aesthetic System is substantially equivalent to its predicate device.
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.
K083900, K071768, K090195, K091446, K073583, K091446, K041086, K033549
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
11 100770
510(k) Summary
Palomar Medical Technologies, Inc.
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
NAME:
ﺔ ﻟﻠﺘﻘﻴﻴﻢ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﺮﺍﺗﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﺮﺍﺗﻴﺔ ﺍﻟﺘﻲ ﺗﺮﺗﻴﺐ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ
に
MAR 2 9 2010
ADDRESS: 15 Network Drive Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 418-1169
Sharon Timberlake, MSHS, RAC, CCRA CONTACT: Director of Regulatory Affairs
DATE PREPARED: January 25, 2010
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Artisan ™ Aesthetic System |
|---|---|
| COMMON/USUAL NAME: | Light and Laser System |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| (21 CFR § 878.4810) |
PRODUCT CODES: GEX, ONG
3. PREDICATE DEVICES
Palomar Medical Technologies, Inc. Lux2940 Handpiece K083900, K071768
Palomar Medical Technologies, Inc. Lux1540 Handpiece K090195. K091446
Palomar Medical Technologies, Inc. Lux1440 Handpiece K073583, K091446
Palomar Medical Technologies, Inc. Palomar StarLux Pulsed Light System K041086, K033549
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4. INTENDED ÜSE
The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.
ડ. DEVICE DESCRIPTION
The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.
6. PERFORMANCE DATA
The review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Artisan Aesthetic System is substantially equivalent to its predicate device.
7. SUBSTANTIAL EQUIVALENCE
The Artisan Aesthetic System is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the Artisan Aesthetic System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, MSHS, RAC, CCRA 15 Network Drive Burlington, Massachusetts 01803
MAR 2 9 2010
Re: K100270
Trade/Device Name: Artisan™ Aesthetic System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and Plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, ONG, ONF Dated: January 28, 2010 Received: January 29, 2010
Dear Ms. Timberlake:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Sharon Timberlake, MSHS, RAC, CCRA
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 1 óć 7 7 o
Device Name: Artisan™ Aesthetic System
Indications for Use:
The Lux2940 Fractional Handpiece optics is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs; and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.
The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
Neil R.P. Ogle for MXM
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100270
Palomar Medical Technologies, Inc. Artisan Aesthetic System
5
The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil SP Qda for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100270