(258 days)
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No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical devices. The description focuses on the physical components and the light energy technology.
Yes
The device is used for surgical applications and hair removal, which are considered therapeutic interventions.
No
The device is indicated for surgical applications (photocoagulation, coagulation, hemostasis) and hair removal/reduction, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a console, control panel, cooling system, and hand-piece, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Dealight IPL Function: The Dealight IPL device uses light energy applied directly to the body (in vivo) for therapeutic purposes (hair removal, tissue coagulation, hemostasis). It does not analyze samples taken from the body.
The information provided clearly describes a device used for direct treatment on the patient's body, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology.
Intense Pulsed Light Energy/Wavelengths (590-1200 nm) 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Dealight Intense Pulsed Light (IPL) is comprised of the following main components:
- A light / laser system console (including software and control electronics)
- A control and display panel
- Air cooling system
- A hand-piece with cut off filters
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)
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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.
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
510 (k) Summary
| Oct. 18, 2004 | Greg Kennebeck – Contact
Europro, Inc.
3952 Camino Ranchero Rd.
Camarillo, CA 93012
Phone: 800-272-1716
Fax: 805-482-9099 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Dealight IPL |
| Common Name: | Laser Powered Surgical Instrument |
| Regulation #: | 878.4810 |
| Regulatory Status: | Class II |
| Product Code: | GEX |
PRODUCT DESCRIPTION
The Dealight Intense Pulsed Light (IPL) is comprised of the following main components:
- A light / laser system console (including software and control electronics) -
- A control and display panel -
- Air cooling system -
- A hand-piece with cut off filters -
INTENDED USE
The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology.
Intense Pulsed Light Energy/Wavelengths (590-1200 nm) 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 re-growing after a treatment regimen.
1
K04 3032
2/
Rationale for Substantial Equivalence
The Dealight is substantial equivalent to Lumenis's/ESC Family of IPL' systems (K030342). The Dealight is comparable to the predicate device in terms of the technical specifications, operating performance features, general physical configuration and intended uses.
Safety and Effectiveness Information
The Dealight conforms with federal regulations and performance standards 21 CFR 1040.10 and 21 CFR 1040.11 for medical laser systems.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2005
Mr. Greg Kennebeck Europro, Inc. 3952 Camino Ranchero Road Camarillo, California 93012
Re: K043032 Trade/Device Name: Dealight IPL Regulation Number: 21 CFR 878.4810 Regulation Name: 21 Crise of 21 Crise of 2018 - 12:00
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 10, 2005 Received: June 14, 2005
Dear Mr. Kennebeck:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becaon 910(tr) premained 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 clerosuly to regally manage of the Medical Device American of the Federal Food. Days commerce provision to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, ulciclefore, market the device, books of the more of registration, listing of general controls provisions of the fiel 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 classinod (600 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to suell additions, 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 Flease be advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a doternations administered by other Federal agencies. You must of any it catal statutes and regulations and and limited to: registration and listing (21 Comply will an the 71et 51equirements)01); good manufacturing practice requirements as set CITY art 807), adeimig (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Greg Kennebeck
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premarket notification: "The PPF intelligention 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 specific advice for Jour as 10 1) 276-01 15. Also, please note the regulation entitled, Conlect the Office of Compunation at (21 t 7 = 1 = = = 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers; International and Oction: http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
to-lit
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K043032 510 (k) Number: Dealight IPL Device Name:
· · · · · · .
Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for:
- The removal of unwanted hair from all skin types, and to effect stable long-term, -The removed of an wadestion in skin types I-V through selective targeting of melanin in hair follicles.
Prescription Use 2 (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)
Euch R
of Of General, Restorative Nemolorical Devic