(114 days)
The Beamer Painlow Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Not Found
The provided text is a 510(k) premarket notification approval letter for the "Beamer Painlow Infrared Light Treatment System". It acknowledges that the device is substantially equivalent to a legally marketed predicate device but does not include any study data, acceptance criteria, or performance metrics.
Therefore, I cannot provide the information requested in your prompt based on the given text.
The document primarily focuses on regulatory approval, stating that the device is substantially equivalent to existing predicate devices for the indicated uses. It does not contain details about:
- Acceptance criteria for device performance
- Reported device performance against any criteria
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established for training data
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Public Health Service
OEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beamline Corporation % Mr. David R. Balzer Official Correspondent 602 Anacapa Irvine, California 92602
Re: K052307
K052307
Trade/Device Name: Beamer Painlow Infrared Light Treatment System
Trade/Device Name: Beamer 2005500 Trade/Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Received: December 5, 2005
Dear Mr. Blazer:
We have reviewed your Section 510(k) premarket notification of intent to market the device
s the indication works in the simpled the daying is substantially equivalent (for t We have reviewed your Section 5 i(t) premarket in circuit in their the indications
referenced above and have device is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the Articles (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. and Cosmetic Act (Act) that do not require approval on the general opprovisions of the Act. The
You may, therefore, market the device, subject to the general controls of the You may, therefore, market the device, subject to the general veninal registration, listing of
general controls provisions of the Act also and replibitions against misbrandin general controls provisions of the Act include requirements for allements.
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 )
Course of the cases of the class of a loss for regulations affecting If your device is classified (see above) mio entirer cass in topedia loos affecting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional controis. Listing major regalato 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In ad be found in the Code of Federal Regulations, This 20, 2017, 11:00 PM
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 Please be advised that FDA's issuance of a substantial with requirements of the Act
that FDA has made a determination that your device compliss with other requirements of You that FDA has made a determination inalyou device compress . You must
or any Federal statutes and regulations administered by not limited to: registration and listi or any Federal statutes and regulations administer or registration and listing (21
comply with all the Act's requirements, including, but not instite requirements as set comply with all the Act s requirements, including, but not mines practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requireme CFR Part 807); labeling (21 CFR Part 801); good manufacturing proficable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, th forth in the quality systems (QS) regulation (21 CFR Paces)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Blazer
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter wai acation. The FDA finding of substantial equivalence of your device to a legally premance noticate 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 If you atem of Compliance at (240) 276-0120. 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, John,
Mark N. Melgreen
Mark N. Melkerson ﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Beamer Painlow 510(k):
STATEMENT of INDICATIONS for USE
510(k) NUMBER (IF KNOWN): K052307
DEVICE NAME: Beamer Painlow Infrared Treatment System
INDICATIONS FOR USE:
The Beamer Painlow Infrared Treatment System is a non-invasive, portable, home use The Beatler Familow infrared Treathen by times of elevating tissue temperaure
device intended to provide topical heating for the purpose of elevating tissue temperaure device intended to provide topical neating for intributing arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Prescription Use (Per 21 CRF 801.109) OR Over-The-Counter-Use I X (Optional Format 1-2-96)
(Please do not write under this line-continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature of Officer or Employee
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Number/052307
N/A