(44 days)
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No
The document describes a light-based medical device and its intended uses, but there is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is intended for the treatment of various medical conditions, including inflammatory Acne Vulgaris, benign pigmented lesions, and benign cutaneous vascular lesions, which are all therapeutic indications.
No
The device is described as an Intense Pulsed Light System intended for various treatments such as hair reduction, acne treatment, and photocoagulation of lesions. Its function is to deliver pulsed light for therapeutic purposes, not to diagnose conditions.
No
The device description explicitly lists hardware components such as a control console unit, display panel, power supply, cooling system, and a removable handpiece with integrated parts. This indicates it is a hardware-based medical device that utilizes light energy, not a software-only device.
Based on the provided text, 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.
- Device Function: The McCue Energist ULTRA™ VPL Intense Pulsed Light System is a light-based medical device that applies pulsed non-ionizing radiation directly to the body for therapeutic purposes (hair reduction, acne treatment, vascular lesions, pigmented lesions). It does not analyze samples taken from the body.
- Intended Use: The intended uses described are all direct treatments applied to the patient's skin.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The McCUE Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- . Intense Pulsed Light Energy / wavelengths (530 - 950nm)
The 530 - 950nm intense pulsed wavelengths are indicated for:
The treatment of mild to moderate inflammatory Acne Vulgaris.
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.
- . Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The McCUE Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system is designed to be compact and self contained and includes the following features:
- . Control console unit
- Display panel .
- Power supply .
- Cooling system .
- Removable handpiece with integrated switch, lamp, filter and glass coupling .
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
McCue Energist ULTRA™, K040659, Cyden IFL Professional System, K050165
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.
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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).
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§ 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.
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Section 5 - 510(k) Summary
VAR 1 5 2006
This 510(k) summary of safety and effectiveness for the McCUE Energist ULTRA variable pulsed light system has been prepared in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows relevant Office of Device Evaluation (ODE) guidance concerning the organisation and content of a 510(k) summary.
5.1 Applicant
McCue Plc,
5.2 Address
McCue Plc, Unit 27 Solent Industrial Estate, Hedge End. Southampton, SO30 2FY. UK
5.3 Contact Person
Steven Peach, General and Technical Manager Telephone (44) 1489 795668 Fax number (44) 1489 795670 Email smp@mccueplc.com
5.3.1 US Agent :
McCue Corporation, Inc. 1 Lisa Marie Circle, Larchwood Estate, Warwick, RI 02886
5.3.2 Name and Address of the Manufacturing Facilities :
McCue Pic, Unit 27 Solent Industrial Estate, Hedge End, Southampton, SO30 2FY. UK
5.3.3 Establishment Registration Number :
9617153
1
5.4 Preparation Date
January 25th, 2006
5.5 Device Trade Name McCUE Energist ULTRA Variable Pulsed Light (VPL™) System
5.6 Device Common Name
Intense Pulsed Light System
5.7 Device Classification
Laser surgical instrument for use in General and Plastic Surgery and Dermatology Product code: GEX 21 CFR 878.4810
5.8 Legally marketed Predicate Devices
McCue Energist ULTRA™, K040659 Cyden IFL Professional System, K050165
5.9 Device Description
The McCUE Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system is designed to be compact and self contained and includes the following features:
- . Control console unit
- Display panel .
- Power supply .
- Cooling system .
- Removable handpiece with integrated switch, lamp, filter and glass coupling . block
5.10 Intended Use
The McCUE Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- Intense Pulsed Light Energy / wavelengths (530 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for:
The treatment of mild to moderate inflammatory Acne Vulgaris.
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemanqiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.
2
. Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types and to effect stable long-term or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
5.11 Comparison of Technological Characteristics
The McCUE Energist ULTRA VPL System has an identical intended use to the McCue predicate system and identical technological characteristics except for modifications to the device software and high voltage component. These differences do not result in differences in performance or raise new questions of safety and efficacy. The McCUE Energist ULTRA VPL System also has the same principles of operation, mode of action and equivalent energy outputs that are used by the Cyden predicate device to achieve the treatment of Acne Vulgaris. Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters. The McCUE Energist ULTRA VPL™ System is therefore concluded to be substantially equivalent to both of the above named predicate devices and minor differences to the systems do not raise additional concerns of safety and efficacy.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
McCue Plc c/o Mr. Steven Peach General and Technical Manager Unit 27 Solent Industrial Estate, Hedge End Southampton, Hampshire SO30 2FY
Re: K060234
Trade/Device Name: McCue Energist ULTRA™ VPL Intense Pulse 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: January 26, 2006 Received: January 30, 2006
Dear Mr. Peach:
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
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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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
elmee.
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): //
Device Name: McCue Energist ULTRATM VPL Intense Pulse Light System
Indications for Use:
The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- . Intense Pulsed Light Energy / wavelengths (530 - 950nm)
The 530 - 950nm intense pulsed wavelengths are indicated for:
The treatment of mild to moderate inflammatory Acne Vulgaris.
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.
- . Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
(Over)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BEL.OW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Elmol
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Section 4
510(k) Number__KO60234