(72 days)
Not Found
No
The summary describes a laser handpiece for soft tissue procedures and does not mention any AI or ML components or functionalities.
Yes
The device is intended for surgical applications involving excision, incision, ablation, vaporization, and coagulation of soft tissue to treat various medical conditions like skin resurfacing, wrinkles, scars, and tumors, which are therapeutic interventions.
No
The device description and intended use focus on surgical applications for excision, incision, ablation, vaporization, and coagulation of soft tissue, not on diagnosing conditions.
No
The device description explicitly states it is composed of a system console, cooling system, power supply, and handpiece, indicating it is a hardware device with multiple physical components.
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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The Palomar Lux2940 handpiece is intended for surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. This involves direct interaction with the patient's body for therapeutic purposes.
- Lack of Specimen Examination: The description does not mention the examination of any biological specimens outside of the body.
The device is a surgical laser handpiece used for treating various soft tissue conditions directly on the patient. This falls under the category of therapeutic medical devices, not in vitro diagnostics.
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, 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 Palomar 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 .
- Superficial skin lesions
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (including 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 specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.
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.
K000023, K010285 & K040005, K042000, K980361
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 Lux2940 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 FEB Phone: (781) 993-2300 Fax: (781) 993-2330
9 2007
7
Sharon Timberlake, RAC, CCRA CONTACT: Director of Regulatory Affairs
DATE PREPARED: November 28, 2006
2. DEVICE INFORMATION
Palomar Lux2940 Handpiece TRADE/PROPRIETARY NAME:
COMMON/USUAL NAME: Er: YAG laser
CLASSIFICATION NAME:
Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR §878.4810)
GEX PRODUCT CODE:
PREDICATE DEVICES 3.
Friendly Light (K000023) Innotech USA
Contour Profile (K010285 & K040005) Sciton, Inc.
Harmony Lovely II (K042000) Alma Lasers Inc. (formerly MSq (M2) Ltd.)
Dermablate (K980361) Aesculap-Meditec
1
4. INTENDED USE
Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes 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
DEVICE DESCRIPTION ട്.
The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.
6. PERFORMANCE DATA
・
The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.
7. SUBSTANTIAL EQUIVALENCE
The Lux2940 handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the Lux2940 also share the same technological characteristics to its predicates.
2/2
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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus in its talons.
ood 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
9 2007 FB
Re: K063571 Trade/Device Name: Palomar Lux2940 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: November 27, 2006 Received: November 29, 2006
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, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
For Pablo Perez
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): ___K063571
Device Name: Palomar Lux2940 Handpiece
Indications for Use:
The Palomar 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 .
- Superficial skin lesions �
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| 510(k) Number | K063577 |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
PALOMAR MEDICAL TECHNOLOGIES, INC. Lux2940 510(K)
CONFIDENTIAL