(69 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is described as treating various medical conditions, including unwanted hair, acne, and pigmented lesions, which are therapeutic interventions.
No
The device is described as treating conditions (hair removal, acne, pigmented lesions) rather than diagnosing them.
No
The device description explicitly states it is a system emitting light radiation and includes hardware components such as capacitors, a Xenon lamp, a control panel, and a handpiece.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Axiom System Function: The Axiom Intense Pulsed Light System is a device that emits light radiation and is used for direct treatment of the body (hair removal, acne treatment, lesion treatment). It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all therapeutic or cosmetic treatments applied directly to the patient's skin.
Therefore, based on the provided information, the Axiom Intense Pulsed Light System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in:
- Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
- Treatment of mild to moderate inflammatory acne (acne vulgaris).
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait
Product codes
GEX
Device Description
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 mm to 1200 mm handpiece. The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of Capacitors in a Xenon ramp, mountou on a hanspires, This generates a rapid and intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box
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
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)
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A database search has been for adverse effects of the device that is currently marketed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022583, K051508, K020856, K020839, K043319, K041095
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
K 062312
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92
1. General Information
Submitter:
General Project, S.r.I. Via della Gora 13/1-15/19 50025 Montespertoli, Florence ltaly
OCT 16 2006
Contact Person:
Cornelia Damsky CDI Regulatory Consultants 56 Westcott Road Stamford, CT 06902 Tel: (203) 323-7535 cdamsky@optonline.net
Summary Preparation Date:
July23, 2006
2. Names
Proprietary Name: Common Name: Classification Name:
Axiom Intense Pulsed Light System IPL System Laser surgical instrument for use in General and Plastic Surgery and in Dermatology. Product Code: GEX, Panel 79
3. Legally Marketed Predicate Devices
General Project's Flash1 (K022583) General Project's Med FlashII (K051508) Radiancy's SpaTouch (K020856) Lumenis' IPL Quantum SR (K020839) Novalis Medical's Clareon Pulsed Light System (K043319) Cynosure's Photosilk Plus (K041095).
The AXIOM Intense Pulsed Light System is substantially equivalent to the Flash 1 and the MedFlash II manufactured by General Project, Montespertoli, Florence, Italy. The AXIOM Intense Pulse Light system shares the same indications for use and the same or similar technological characteristics including: controls and displays and light source.
1
4. Device Description
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of range from 590 mm to 1200 mm to 1200 mm handpiece. This generates a rapid and Capacitors in a Xenon ramp, mountou on a hanspires include the charge intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box
5. Intended Use
The Axiom Intense Pulsed Light System is intended for treatment of mild to moderate inflammatory acne (acne vulgaris), removal of unwanted hair from all skin types and to inflammatory ache (acho valgano), For reduction. The Axiom is also indicated for effect stable, forig-term or permanent half readerneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait
6. Performance Data
- Ferformance data is required for this Class II device nor requested by the Food and No performanos data is roquire Evaluation). A database search has been drug Administration (Onloo of BONee Effects of the device that is currently marketed.
No data submitted for section 807.92 6[(b)(1)(2)(3c). See attached documentation of adverse effects.]
Conclusion:
The AXIOM Intense Pulsed Light System is substantially equivalent to the Flash 1 and The AXIOM Intense Pulse Light System shares the same indications for Med Hash in: "The ARCH as the predicate Intense Pulsed Light Systems.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2006
General Project, S.r.l % CDI Regulatory Consultants Ms. Cornelia Damsky 56 Westcott Road Stamford, Connecticut 06902
Re: K062312 Trade/Device Name: AXIOM Intense Pulsed Light System 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: August 4, 2006 Received: August 9, 2006
Dear Ms. Damsky:
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.
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Page 2 – Ms. Cornelia Damsky
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 vours,
Kof
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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U.S. Food and Drug Ad
RESERVED RIGHTS
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Indications for Use
510(k) Number (if known): K062312
Device Name: AXIOM Intense Pulsed Light System
Indications for Use:
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in:
- Removal of unwanted hair from all skin types and to effect stable long-term or • permanent, hair reduction
- Treatment of mild to moderate inflammatory acne (acne vulgaris) .
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, � scars, striae, lentigines, nevi, melasma and cafè-au-lait
Prescription Use
(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 OF NEEDED)
Concurrence of CDRHA Office of Device Evaluation (ODE)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K062312