Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
Treatment of inflammatory acne (acne vulgaris)
Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

Device Description

The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intense Pulsed Light.
The Med flash II system contains five principal components:

Charge system of the capacitors .
Electronic control system .
Control panel .
Handpiece with exchangeable lamp box ●
Handpiece cooling system .

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the MED flash II Intense Pulsed Light System:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Measure/Acceptance Criteria	Reported Device Performance	Comments
Specific Performance Data	None Presented	The 510(k) summary explicitly states "None presented" under the "Performance Data" section.
Premarket Equivalence to Predicate Devices	Substantially equivalent to (K041086, K033549), Palomar's EsteLux V (K040081), Palomar's EsteLux G (K020941), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K043319), Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K041095) and General Project's Flash 1 (K022583).	The device's "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a combination of several predicate devices. This means that if the predicate devices were deemed safe and effective for their indications, and the subject device is similar enough, then the subject device is also considered safe and effective.
Indications for Use (Implicit Acceptance)	- Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction - Treatment of inflammatory acne (acne vulgaris) - Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait - Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins - Integrated cooling handpiece intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.	The device is deemed acceptable for these indications based on its substantial equivalence to predicate devices that have similar indications and technological characteristics.
Technical Specifications (Implicit Acceptance for Equivalence)	- Emitting light radiation in the range from 590 nm to 1200 nm. - Based on quick power discharge of capacitors in a Xenon lamp. - Handpiece with exchangeable lamp box. - Handpiece cooling system.	These technical specifications are presented in the device description, implying that they align with or are sufficiently similar to the predicate devices to support substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "None presented" under the "Performance Data" section. This indicates that no specific test set data, sample size, or information on data provenance (country of origin, retrospective/prospective) was provided or required for this 510(k) submission. The approval was based on demonstrating substantial equivalence to predicate devices, not on new clinical performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. Since no specific performance data or test set was presented, there was no ground truth to be established by experts in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As no test set data was presented, no adjudication method was mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "None presented" for performance data. There is no mention of an MRMC study, or any comparative effectiveness study with or without AI assistance. This type of study would typically be part of a robust performance data section, which is absent here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/No. This device is an Intense Pulsed Light System, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance without human interaction is not relevant to its type. The 510(k) summary does not mention any software or AI components that would require such a study.

7. The Type of Ground Truth Used

No specific ground truth type was used or reported in the context of a new performance study. The basis for clearance is substantial equivalence to predicate devices. This implies that the safety and effectiveness of the device are inferred from the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. As the approval is based on substantial equivalence to existing predicate devices and no new performance study data was presented, there are no references to a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. Since no training set was mentioned in this 510(k) summary, there is no information on how a ground truth for a training set would have been established.

Summary

{0}------------------------------------------------

OCT 5 - 2005

510(k) Summary of Safety and Effectiveness for the MED flash II Intense Pulsed Light System

KOSIZOR

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	General Project S.r.l.Via della Gora 15/1950025 MontespertoliFirenze, Italy
Contact Person:	Maureen O'Connell5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246
Summary Preparation Date:	June 1, 2005

Names

Device Name:	MED flash II Intense Pulsed Light System
Classification Name:	Laser Instrument, Surgical PoweredProduct Code: GEXPanel: Dermatology and Plastic Surgery

3. Predicate Devices

The MED flash II Intense Pulsed Light System is substantially equivalent to a combination of the following devices: Palomar's StarLux V (K041086, K033549), Palomar's EsteLux V (K040081), Palomar's EsteLux G (K020941), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K043319), Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K041095) and General Project's Flash 1 (K022583).

4. Device Description

{1}------------------------------------------------

The Med flash II system contains five principal components:

Charge system of the capacitors .
Electronic control system .
Control panel .
Handpiece with exchangeable lamp box ●
Handpiece cooling system .

5. Indications for Use

The MED flash II Intense Pulsed Light System which is generally indicated for use in:

Removal of unwanted hair from all skin types and to effect stable long-term or . permanent, hair reduction
. Treatment of inflammatory acne (acne vulgaris)
Treatment of benign pigmented epidermal and cutaneous lesions including warts, . scars, striae, lentigines, nevi, melasma and café-au-lait
. Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacca, facial and leg veins
The integrated cooling handpiece is intended to provide pre-cooling of the . epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.
1. Performance Data

None presented.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 - 2005

General Project S.r.l. c/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K051508 Trade/Device Name: MED flash II 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: August 25, 2005 Received: August 26, 2005

Dear Ms. ()'Connell:

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 cither 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 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}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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/cdrl/dsma/dsmamain.html

ncerely vours.

Barbara Bruckner

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known)

MED flash II Intense Pulsed Light System Device Name

Indications for Use:

The MED flash II Intense Pulsed Light System is indicated for use in:

Removal of unwanted hair from all skin types and to effect stable long-term or . permanent, hair reduction
Treatment of inflammatory acne (acne vulgaris) .
Treatment of benign pigmented epidermal and cutaneous lesions including warts, . scars, striae, lentigines, nevi, melasma and café-au-lait
Treatment of vascular lesions, including port wine stains, hemangiomas, . angiomas, telangiectasias, rosacea, facial and leg veins
The integrated cooling handpiece is intended to provide pre-cooling of the . epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use

(Optional Format 1-2-96)

Chulare Pradeep

Division of General, Restorative, and Neurological Devices

510(k) Number K051508

Regulation Number and Section

§ 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.