(30 days)
Not Found
No
The document describes a laser handpiece for soft tissue ablation and resurfacing, and there is no mention of AI or ML in the intended use, device description, or performance studies summary.
Yes
The device is intended for various surgical applications involving soft tissue, including skin resurfacing, treatment of wrinkles, and scar revision, which are therapeutic interventions aimed at improving or treating a condition.
No
The provided text describes the Palomar Erbium handpiece's intended use for surgical applications involving the excision, incision, ablation, vaporization, and coagulation of soft tissue. These are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description explicitly states it is a "Handpiece" that "attaches to the StarLux Pulsed Light and Laser System," which includes hardware components like a console, chiller, and footswitch. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on soft tissue, involving excision, incision, ablation, vaporization, and coagulation. This is a direct treatment of the patient's body.
- Device Description: The description details a handpiece that attaches to a laser system, used for delivering energy to tissue. This aligns with a therapeutic or surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical sites listed are parts of the living body being treated directly.
- Performance Studies: The summary of performance studies focuses on substantial equivalence to a predicate device used for similar surgical applications.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is used on the body for therapeutic and surgical purposes.
N/A
Intended Use / Indications for Use
Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, telangicctasia, 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 Palomar Erbium 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 .
- Superficial skin lesions .
Product codes
GEX
Device Description
The Palomar Erbium Handpiece attaches to the StarLux Pulsed Light and Laser The complete system consists of a cart, system console, chiller, a System. footswitch, and a handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Erbium Handpiece is substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary Palomar Erbium Handpiece
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
NAME: Palomar Medical Technologies, Inc.
82 Cambridge Street ADDRESS: Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 993-2330
Sharon Timberlake, RAC, CCRA CONTACT: Director of Regulatory Affairs
DATE PREPARED: April 24, 2007
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Palomar Erbium Handpiece |
|---|---|
| COMMON/USUAL NAME: | Erbium Laser |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| (21 CFR §878.4810) | |
| PRODUCT CODE: | GEX |
3. PREDICATE DEVICE
Lux2940 Handpiece K063571 Palomar Medical Technologies, Inc.
4. INTENDED USE
Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, telangicctasia, 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.
1
DEVICE DESCRIPTION 5.
The Palomar Erbium Handpiece attaches to the StarLux Pulsed Light and Laser The complete system consists of a cart, system console, chiller, a System. footswitch, and a handpiece.
PERFORMANCE DATA 6.
The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Erbium Handpiece is substantially equivalent to its predicate device.
7. SUBSTANTIAL EQUIVALENCE
The Palomar Erbium Handpiece was found to be substantially equivalent to its predicate device when used according to its intended use. The information that is provided in this application demonstrates that the Palomar Erbium Handpiece also shares the same technological characteristics as its predicate.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
Re: K071152
Trade/Device Name: Palomar Erbium Handpiece 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: April 24, 2007 Received: April 26, 2007
MAY 2 5 2007
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.
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.
3
Page 2 -- Ms. Sharon Timberlake, RAC, CCRA
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, "Mishranding 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMahon
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Palomar Erbium Handpiece
Indications for Use:
The Palomar Erbium 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 .
- Superficial skin lesions .
Mark A. Miller
(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devices
510(k) Number K071152
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)