(88 days)
K# 030423, K#030527
K# 030423,K#030527
No
The summary describes an intense pulsed light system for various dermatological and cosmetic treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for use in various medical treatments such as tattoo removal, treatment of benign pigmented lesions, cutaneous lesions, vascular lesions, and unwanted hair removal, which are all therapeutic applications.
No
The device is indicated for treatment and removal of various conditions (tattoos, lesions, hair), which are therapeutic applications, not diagnostic ones.
No
The device description explicitly states it consists of a light system console (including software and control electronics), a control and display panel, and one or more attached hand-pieces, indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical, aesthetic, and cosmetic applications directly on the patient's body (treatment of tattoos, lesions, vascular issues, hair removal).
- Device Description: The device description details a system that delivers pulsed light, applied externally via hand-pieces.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed for direct therapeutic and cosmetic treatment on the body.
N/A
Intended Use / Indications for Use
An intense pulsed light, the Powerlite 600® EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
- The treatment of tattoos; .
- The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles);
- The treatment of 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, erythema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, . or permanent, hair reduction in skin types I-V.
Product codes
GEX
Device Description
The Powerlite 600® EX System delivers pulsed light at a wavelength beginning at a wavelength of 515nm. The device consists of three interconnected sections: a light system console (including software and control electronics), a control and display panel; and one or more attached hand-piece(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; cutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialties of general and plastic surgery, and dermatology
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
Non-Applicable
Key Metrics
Not Found
Predicate Device(s)
K# 030423. Powerlite600® EP System, K#030527, Vasculight, Model SR - Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems
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
Exhibit #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:_KO333933
1. . Submitter's Identification:
Preswede AB Flojelbergsgatan 8A 431 35 Molndal, Sweden
Date Summary Prepared: December 18, 2003
Contact: Mr. John Wilhelmsson, President
2. Name of the Device:
Powerlite 600® EX System.
3. Predicate Device Information:
K# 030423. Powerlite600® EP System, Preswede AB, Sweden K#030527, Vasculight, Model SR - Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems, Lumenis, Inc.
4. Device Description:
The Powerlite 600® EX System delivers pulsed light at a wavelength beginning at a wavelength of 515nm. The device consists of three interconnected sections: a light system console (including software and control electronics), a control and display panel; and one or more attached hand-piece(s).
5. Intended Use:
An intense pulsed light, the Powerlite 600® EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoaqulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
- The treatment of tattoos; .
- The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles);
1
- The treatment of 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, erythema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, . or permanent, hair reduction in skin types I-V.
Comparison to Predicate Devices: 6.
The Powerlite 600® EX System and the Vasculight/Powerlite 600® EP devices are very similar or identical in terms of the device structure and its technology. Both systems are electro-optical medical devices designed for effective photothermal treatment.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Electrical and EMC testing per IEC 60601-1 and IEC 60601-1-2 requirements
Discussion of Clinical Tests Performed: 8.
Non-Applicable
9. Conclusions:
The Powerlite 600® EX System has the same intended use and similar characteristics as the Lumenis family of Intense Pulsed Light (IPL), Vasculight, Model SR and the Powerlite 600® EP System. Moreover, documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Powerlite 600® EX System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2004
Preswede AB c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K033933 Trade/Device Name: Powerlite 600® EX 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 18, 2003 Received: December 19, 2004
Dear Ms. Goldstein-Falk:
Wc 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 markcted 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 (sce 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 docs 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.
3
Page 2 - Ms. Susan D. Goldstein-Falk
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 (301) 594-4659. 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 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
Exhibit B
Page
510(k) Number (if known): 〈○る>933
Device Name: Powerlite 600® EX System
Indications For Use:
An intense pulsed light, the Powerlite 600® EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
- The treatment of tattoos; .
- The treatment of benign pigmented epidermal lesions including . dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- The treatment of 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, ervthema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable . long-term, or permanent, hair reduction in skin types I-V.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) |
Division of General, Restorative,
and Neurological Devices
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 510(k)) Number | K033933 OR Over-The Counter Use (Optional Format 1-2-96) |