(83 days)
Not Found
No
The summary describes a device that uses thermal energy from a light source for hair removal and does not mention any AI or ML components or functionalities.
No
The device is described as being for "aesthetic and cosmetic use" and "removal of hair," which are typically not considered therapeutic purposes.
No
The device is described for "aesthetic and cosmetic use" and "removal of hair," which are not diagnostic purposes. It applies thermal energy for treatment, not for identifying diseases or conditions.
No
The device description explicitly states it is constructed from hardware components including a Man Machine Interface panel, an operating console, and a treatment hand piece, and applies thermal energy via a flash light source.
Based on the provided information, the BEAMAX device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "aesthetic and cosmetic use" for "removal of hair by using selective light energy." This is a direct treatment applied to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device that applies thermal energy to human skin tissue via a hand piece in contact with the skin. This is consistent with a therapeutic or cosmetic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The BEAMAX's function is to directly interact with the body for a cosmetic purpose.
N/A
Intended Use / Indications for Use
The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.
Product codes
GEX
Device Description
The BEAMAX applies thermal energy to human skin tissue. The energy is transmitted from a flash light source. It is transmitted to the target tissue by a hand piece that is in contact with the skin (contact mode).
The device is constructed from a Man Machine Interface panel, an operating console, and a treatment hand piece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 device has been designed, verified and validated complying with the 21CFR 820.30 regulations. Bench and clinical data demonstrate that the BEMAX meets the required specifications. No adverse affects have been detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033946 Lovely I (Aria)
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
K063249
510(k) Summary of Safety and Effectiveness (in.accordance to 21 CFR 807.87(h)
Device Name
Proprietary Device Name: BEAMAX
Establishment Name and Registration Number of Submitter
Name: Medic SharpLight Ltd. Registration: In process Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
Product Code: Regulation Number: Common Name: Classification Name:
GEX 878.4810 Pulsed light hair removal system Laser surgical instrument for use in general and plastic surgery and in dermatology. Class II
Regulatory class:
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
K033946 Lovely I (Aria)
Device Description
The BEAMAX applies thermal energy to human skin tissue. The energy is transmitted from a flash light source. It is transmitted to the target tissue by a hand piece that is in contact with the skin (contact mode).
The device is constructed from a Man Machine Interface panel, an operating console, and a treatment hand piece.
Indications for use
The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.
Safety & Effectiveness
The device has been designed, verified and validated complying with the 21CFR 820.30 regulations. Bench and clinical data demonstrate that the BEMAX meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is Medic SharpLight opinion that the BEAMAX is substantially equivalent in terms of safety and effectiveness to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol that resembles a stylized caduceus or a representation of human figures. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medic SharpLight Ltd. % Quasar Quality Ltd. Mr. Dan Laor Managing Director 6 Sireni Street Haifa 32972 Isreal
JAN 17 2007
Re: K063249 Trade/Device Name: BEAMAX 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 23, 2006 Received: December 1, 2006
Dear Mr. Laor:
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.
2
Page 2 - Mr. Dan Laor
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
F-R
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K063249 510(k) Number (if known):
BEAMAX Device Name:
Indications For Use: The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: NO (Part 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number L063249