(138 days)
Not Found
No
The 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the laser technology and its components.
Yes
The device is described as being used for dermatological procedures such as skin resurfacing, treatment of pigmented lesions, and treatment of facial wrinkles and fine lines, which are considered therapeutic applications.
No
The Emerge Fractional Laser is described as being used for "dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures" and for "treatment of pigmented lesions" and "facial wrinkles and fine lines." These are all treatment applications, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states it consists of a fractional laser handpiece attached to a base unit with hardware components like a power supply, control electronics, and LCD screen. This is a hardware 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 states the device is for "dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures," and for treating various skin conditions like pigmented lesions and wrinkles. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a laser handpiece and base unit, consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of specimens.
Therefore, the Emerge Fractional Laser is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
Product codes
GEX, ONG
Device Description
The Emerge Fractional Laser consists of a fractional laser handpiece attached to a base unit. The base unit includes a power supply, control electronics, and user interface LCD screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, facial
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K103664, K090525, K063808, K110349
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
NOV 1 4 2011
510(k) Summary
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
SUBMITTER'S INFORMATION 1.
| NAME: | Palomar Medical Technologies, Inc. |
|---|---|
| ADDRESS: | 15 Network Drive |
| Burlington, MA 01803 | |
| Phone: (781) 993-2300 | |
| Fax: (781) 418-1169 | |
| CONTACT: | Sharon Timberlake, MSHS, RAC, CCRA |
| Director of Regulatory Affairs |
DATE PREPARED: November 7, 2011
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Emerge Fractional Laser |
|---|---|
| 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 |
PREDICATE DEVICES 3.
Palomar Medical Technologies, Inc. Palomar Icon™ Aesthetic System Lux1440 Handpiece K103664
Palomar Medical Technologies, Inc. LOI System (PaloVia™) K090525
Reliant Technologies, Inc. (Now Solta Medical, Inc.) Fraxel IV SR Laser System (Re:fine™) K063808
Solta Medical, Inc. Clear+Brilliant Laser System K110349
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4. INTENDED USE
The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
న. DEVICE DESCRIPTION
The Emerge Fractional Laser consists of a fractional laser handpiece attached to a base unit. The base unit includes a power supply, control electronics, and user interface LCD screen.
6. SUBSTANTIAL EQUIVALENCE
The Emerge Fractional Laser is substantially equivalent to its predicate devices when used according to its intended use. The review of the technological characteristics, mechanism of action, indications for use, clinical data, histology data, and verification as well as validation information provided in the 510(k) Premarket Notification demonstrates that the Emerge Fractional Laser is substantially equivalent to its predicate device. Thus, substantial equivalence is therefore justified.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 4 2011
Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 15 Network Drive Burlington, Massachusetts 01803
Re: K111840
Trade/Device Name: Emerge Fractional Laser 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: ONG Dated: November 07, 2011 Received: November 09, 2011
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.
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Page 2 - Sharon Timberlake, MSHS, RAC, CCRA
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); medical device reporting (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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melke 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):
Device Name: Emerge Fractional Laser
Indications for Use:
The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R.P. Ryde for mkrg
(Division Sign-Cil) Division of Surgical, Orthopedic, and Restorative Devices
11 1840 510(k) Number.
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PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): EMERGE FRACTIONAL LASER CONFIDENTIAL PAGE 1