(134 days)
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No
The provided text describes an Intense Pulsed Light system and its intended uses for various dermatological conditions. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided sections.
Yes
The device is intended for the treatment of various medical conditions such as Acne Vulgaris, vascular lesions, and pigmented lesions, which constitutes a therapeutic purpose.
No
Explanation: The device description focuses on its therapeutic applications such as hair reduction and treatment of various skin conditions using intense pulsed light, with no mention of diagnosing diseases or conditions.
No
The device description explicitly states "Intense Pulsed Light System" and mentions "Intense Pulsed Light Energy / wavelengths," indicating it is a hardware device that emits light energy for treatment, not a software-only device.
Based on the provided information, 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 Energist ULTRA™ VPL Intense Pulsed Light System uses light energy applied directly to the body for therapeutic purposes (hair reduction, acne treatment, vascular and pigmented lesion treatment). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses are all direct treatments applied to the patient's skin.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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 " 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.
Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Energist ULTRAPLUSTM VPL Intense Pulsed Light System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Intense Pulsed Light
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)
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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.
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
FEB - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Energist. Ltd. % Mr. Tim Major Engineering Director Clos Llyn Cwm, Valley Way Enterprise Park, Swansea, SA6 8QY United Kingdom
Re: K082825
Trade/Device Name: Energist ULTRAPLUSTM 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: December 4, 2008 Received: December 8, 2008
Dear Mr. Major:
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
1
Page 2 - Mr. Tim Major
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark N. Mullerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K 082825
Energist ULTRAPLUS™ VPL Intense Pulsed Light System Device Name:
Indications for Use:
The 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 " 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.
Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(Over)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH | (Division Sign-Off) (ODE) |
|---|---|
| --------------------- | --------------------------- |
Division of General, Restorative, and Neurological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |
| Section 4 | Confidential | Page 2 |
|---|---|---|
| ----------- | -------------- | -------- |