(81 days)
Not Found
No
The summary describes a light-based medical device for hair reduction and skin treatments, focusing on wavelengths and physical components. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is intended for permanent hair reduction and photocoagulation of various dermatological lesions, which are therapeutic interventions.
No
The device's intended use and indications for use describe treatments such as hair reduction, photocoagulation of lesions, and photothermolysis, all of which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "light-based medical device" and lists several hardware components including a control console, display panel, power supply, cooling system, and a removable handpiece. This indicates it is a physical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "permanent hair reduction," "photocoagulation of dermatological vascular lesions," "photothermolysis of blood vessels," and the "treatment of benign pigmented lesions." These are all therapeutic or cosmetic procedures performed on the patient's body.
- Device Description: The description details a "light-based medical device that delivers a beam of pulsed non-ionising radiation." This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or the analysis of biological samples.
Therefore, the McCue Energist ULTRATM VPL Intense Pulsed Light System is a therapeutic/cosmetic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 long-term or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Product codes
GEX
Device Description
The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: Control console unit Display panel Power supply Cooling system Removable handpiece with integrated switch, lamp, filter and glass coupling block
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
The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy.
Key Metrics
Not Found
Predicate Device(s)
K020839, K020856, K030897, K020453, K020941, K013365, K022568, K023081
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
JUN - 1 2004
510(k) Summary
McCue Energist ÙLTRA™ Pulsed Light System
This 510(k) summary of safety and effectiveness for the McCue Energist ULTRA pulsed light system by McCue Plc is submitted in accordance with the requirements of the Safe light System by MoSdo 11616 cabinitiations the Office of Device Evaluation (ODE) guidance concerning the organisation and content of a 510(K) summary.
| Applicant: | McCue Plc |
|---|---|
| Address: | Unit 27 Solent Indust. Estate, Hedge End, Southampton. SO23-2FY. England |
| Contact Person: | Steven Peach (General and Technical Manager) |
| Telephone: | 44 1489 795668 |
| Preparation Date: | 19th February 2004 |
| Device Trade Name: | McCue Energist ULTRA™ |
| Common Name: | Intense Pulsed Light System |
| Classification Name: | Laser surgical instrument for use in General and Plastic surgery and Dermatology |
| 21 CFR 878.4810 | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Devices: | The McCue Energist ULTRA™ is substantially equivalent to the following currently marketed devices: |
| Lumenis, Inc. IPL Quantum, K020839 | |
| Radiancy, Inc. SpaTouch, K020856 | |
| Radiancy, Inc. Skin Station, K030897 | |
| Palomar, Inc. EsteLux, K020453, K020941 | |
| Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 | |
| System Description: | The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: |
| Control console unitDisplay panelPower supplyCooling systemRemovable handpiece with integrated switch, lamp, filter and glass coupling block | |
| Intended Use: | The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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
long-term or permanent1 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. |
| Performance
Data: | The differences in specifications of the McCue Energist ULTRA™ and the
predicate devices do not result in different performance or raise new questions of
safety and efficacy. |
| Conclusion: | Based on the foregoing, the McCue Energist ULTRA™ system is substantially
equivalent to the legally-marketed predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, overlaid on a circle of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
McCue PLC c/o Mr. John W. Howlett British Standards Institution Maylands Avenue Hemel Hempstead Herts HP2 4SQ United Kingdom
Re: K040659
K040037
Trade/Device Name: McCue Energist ULTRA™ VPL 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: May 12, 2004 Received: May 20, 2004
Dear Mr. Howlett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your connect the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with 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 r ou may, dierelevely, mains 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 If your device is exassinod (ional controls. Existing major regulations affecting your device can may be subject to sateral 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 r lease be actived that Fermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edolar statuated and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 0077, adoning (21 CFR Part 820); and if applicable, the electronic form in the quality by store (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. John W. Howlett
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse of substantial equivalence of your device to a legally premits to the month on 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 desire spocente at (301) 594-4659. Also, please note the regulation entitled, Comaci the Office of Companies and (set notification" (21CFR Part 807.97). You may obtain Misolanding of Yeleronoo to premainters with 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): __ K040659
Device Name: _ McCue Energist ULTRA™ VPL Intense Pulsed Light System
Indications for Use:
The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 long-term or permanent " 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K040659
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