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K Number
K051508
Device Name
MED FLASH II INTENSE PULSED LIGHT SYSTEM.
Manufacturer
GENERAL PROJECT S.R.L.
Date Cleared
2005-10-05

(120 days)

Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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 .
More Information

K041086, K033549, K040081, K020941, K020839, K043319, K050047, K041095, K022583

Not Found

No
The summary describes a standard Intense Pulsed Light system with electronic controls and a cooling system. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, treatment planning, or other functions.

Yes
The device is indicated for the treatment of various medical conditions such as inflammatory acne, benign pigmented lesions, and vascular lesions.

No

The device description and intended use focus on treatment applications (e.g., hair removal, treatment of acne, lesions, vascular lesions) rather than providing diagnostic information or aiding in diagnosis.

No

The device description clearly outlines multiple hardware components, including a charge system, electronic control system, control panel, handpiece with lamp box, and a handpiece cooling system. This is not a software-only device.

Based on the provided information, the MED flash II Intense Pulsed Light System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended uses listed are all related to treating conditions directly on the patient's skin (hair removal, acne, pigmented lesions, vascular lesions). IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
  • Device Description: The description details a system that emits light radiation and applies it to the body. This is consistent with a therapeutic or aesthetic medical device, not a diagnostic one that analyzes samples.
  • Anatomical Site: The anatomical sites mentioned are all external to the body (skin, epidermis, veins). IVD devices typically interact with internal bodily fluids or tissues.

In summary, the MED flash II is a device that applies energy to the body for treatment purposes, which is the definition of a therapeutic or aesthetic medical device, not an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes

GEX

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 Intensc 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 .

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

None presented.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K041086, K033549, K040081, K020941, K020839, K043319, K050047, K041095, K022583

Reference Device(s)

Not Found

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)

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

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 15/19
50025 Montespertoli
Firenze, Italy |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | June 1, 2005 |

  1. Names
Device Name:MED flash II Intense Pulsed Light System
Classification Name:Laser Instrument, Surgical Powered
Product Code: GEX
Panel: 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

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 Intensc Pulsed Light.

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