(276 days)
Not Found
No
The summary describes a standard IPL system based on selective thermolysis and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for medical conditions such as moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions. It also causes a physiological change (permanent hair reduction), which are characteristics of a therapeutic device.
No
The device is an IPL system indicated for surgical, aesthetic, and cosmetic applications such as hair reduction and treatment of acne, pigmented lesions, and vascular lesions. It does not perform diagnostic functions.
No
The device description explicitly states it is an "intense pulsed light system which delivers intense pulsed light" and includes a "hand piece used to deliver pulsed-light energy," indicating it is a hardware device. The performance studies also focus on electrical safety and performance characteristics of a physical device.
Based on the provided text, 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 description clearly states that the PlatinumGMT™ IPL System Cloud device is an intense pulsed light system that delivers light energy to the skin for various aesthetic and cosmetic applications (hair reduction, acne, pigmented and vascular lesions).
- No mention of samples: There is no indication that this device analyzes any samples taken from the body. It directly interacts with the skin.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and vascular lesions.
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Product codes
ONF
Device Description
The PlatinumGMT™ IPL System Cloud device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 560 nm-1200 nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions.
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)
Bench tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following: (a) IEC 60601-1-2 Edition 3:2007-03, medical electrical equipment - Part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests
(b) IEC 60601-1. Medical Electrical Equipment- Part 1: General Requirements for Safety. 1988: Amendment I, 1991-II, Amendment 2, 1995.
(c) IEC 60335-2-27 ed 4.0 Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation
(d) IEC 60335-1 Safety of household and similar electrical appliances - General
(e) EN 55014-1:2008 Electromagnetic compatibility - Reguirements for household appliances, electric tools and similar apparatus -- Part 1: Emission; Harmonics IEC 61000-3-2; Flicker IEC 61000-3-3
(f) EN 55014-2 (HHA Immunity Standard ); Electrostatic Discharge IEC 61000-4-2 (±6kV Contact ±8kV Air); Radiated RF IEC 61000-4-3 (80 – 2500 MHz 3V/m); Electrical Fast Transients IEC 61000-4-4 (±2kV AC mains ±1kV other); Surge IEC 61000-4-5 (±1kV Differential ±2kV Common; Conducted RF IEC 61000-4-6 (3Vrms, 0.15 – 80 MHz); IEC 61000-4-11 Voltage Dips and Interrupts (>95%V for 0.5 Cycle 60%V for 5 Cycles).
(q) Performance Test (output energy, spot size)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Global Medical Technology S.L. % Mr. George J. Hattub Medicsense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K140668
Trade/Device Name: PlatinumGMT™ IPL System Cloud Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: November 16, 2014 Received: November 24, 2014
Dear Mr. Hattub:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K140668:
Device Name: PlatinumGMT™ IPL System Cloud
Indications For Use: The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and vascular lesions.
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
510(k) Summary
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the office of Device Evaluation (ODE) guidance concerting the organization and content of a 510(k) summary.
The assigned 510(k) Number: K140668
- Date of Submission: December 5, 2014
2. Sponsor
GLOBAL MEDICAL TECHNOLOGY S.L. C/ Isla de Alegranza, 2 (Nave 51) - CP 28703 - San Sebastián de los Reyes - Madrid -ESPANA Teléfono: (+34) 902 024 191 www.gmt-europa.com Contact Person: Name: Derliz David Díaz Title: Operations Manager Phone number: +52-155-4858-7812 E-mail: derliz.diaz@gmt-europa.com
3. Submission Correspondent
George J. Hattub Medicsense, USA 291 Hillside Avenue Somerset, MA 02726 Tel: 508-479-6116 Email: ghattub@comcast.net
4
4. Proposed Device Identification
Proposed Device Name: PlatinumGMT™ IPL System Cloud Classification: Class II Product Code: ONF Regulation Number: 21 CFR 878.48 I 0 Review Panel: General and Plastic Surgery
Indications for Use
The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and vascular lesions.
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment reqimen.
| Filter Setting and | Skin Types | |||||
|---|---|---|---|---|---|---|
| Condition | Wavelength Range | I | II | III | IV | V |
| Hair Reduction | 695-1200 | 695-1200 | 695-1200 | 695-1200 | 755-1200 | |
| Acne | 430-1200 | 430-1200 | 430-1200 | 430-1200 | ---------- | |
| Vascular Lesions | 560-1200 | 560-1200 | 560-1200 | 560-1200 | ---------- | |
| Pigmented Lesions | 560-1200 | 560-1200 | 560-1200 | 560-1200 | ---------- |
5. Predicate Device Identification
510(k) Number: K131859
Product Name: Multifunctional Series
Manufacturer: Beijing Honkon Technologies Co., Ltd.
510(k) Number: K122995
Product Name: Intense Pulse Light (IPL) Systems/ MED-210/230
Manufacturer: Beijing Kes Biology Technology Co., Ltd.
5
6. Device Description
The PlatinumGMT™ IPL System Cloud device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 560 nm-1200 nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions.
7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following: (a) IEC 60601-1-2 Edition 3:2007-03, medical electrical equipment - Part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests
(b) IEC 60601-1. Medical Electrical Equipment- Part 1: General Requirements for Safety. 1988: Amendment I, 1991-II, Amendment 2, 1995.
6
(c) IEC 60335-2-27 ed 4.0 Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation
(d) IEC/EN 60335-1 Safety of household and similar electrical appliances - General
(e) EN 55014-1:2008 Electromagnetic compatibility - Reguirements for household appliances, electric tools and similar apparatus -- Part 1: Emission; Harmonics IEC 61000-3-2; Flicker IEC 61000-3-3
(f) EN 55014-2 (HHA Immunity Standard ); Electrostatic Discharge IEC 61000-4-2 (±6kV Contact ±8kV Air); Radiated RF IEC 61000-4-3 (80 – 2500 MHz 3V/m); Electrical Fast Transients IEC 61000-4-4 (±2kV AC mains ±1kV other); Surge IEC 61000-4-5 (±1kV Differential ±2kV Common; Conducted RF IEC 61000-4-6 (3Vrms, 0.15 – 80 MHz); IEC 61000-4-11 Voltage Dips and Interrupts (>95%V for 0.5 Cycle 60%V for 5 Cycles).
(q) Performance Test (output energy, spot size)
8. Technological Characteristics Comparison
The proposed device has the same technological characteristics with the predicate devices, such as light medium, wavelength, control method and intended use.
9. Substantially Equivalent Conclusion
The wavelength range, energy density, pulse delays and duration of the proposed device are similar to the predicate devices, the slight differences are not considered to affect safety and efficacy.
Based on the comparison and analysis below, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.
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Substantial Equivalence Comparison
| ITEM | Proposed Device
PlatinumGMT™ IPL
System (CLOUD) | Predicate Device
Multifunctional Series
(K131859) | Predicate Device
Intense Pulsed Light
(IPL) Systems
(K122995) | Pulse Delay | 1-99ms | 0.1-40ms | 5-50ms |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------------|-------------------------|----------------------------------------|
| Product
Code | ONF | ONF | ONF | Pulse
Duration | 1-9.9 ms | 1-25ms | 1-14ms |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Maximum Power | 1200W | 2000W | 1400W (MED-210)
2000W (MED-230) |
| Class | II | II | II | Power
Supply | AC 230V +/- 20V
50Hz/60Hz
12A | unknown | 220V+/-20V 50Hz
110V+/-20V 60Hz |
| Intended
Use | The PlatinumGMT™
IPL System Cloud
device (inclusive of the
hand piece used to
deliver pulsed light
energy) is indicated for
use in surgical,
aesthetic and cosmetic
applications in
permanent hair
reduction; moderate
inflammatory acne ,
benign cutaneous
pigmented, and
vascular lesions.
Permanent hair
| The Multifunctional
Series device (inclusive
of the handpiece used
to deliver pulsed-light
energy) are indicated
for use in
surgical, aesthetic and
cosmetic applications in
hair removal, moderate
inflammatory acne
vulgaris, and benign
cutaneous
vascular lesions. | The Intense Pulsed
Light (IPL) Systems
(inclusive of the
handpiece used to
deliver pulsed-light
energy) are indicated
for use in surgical,
aesthetic and cosmetic
applications in
permanent hair
reduction, treatment of
pigmented lesions,
moderate inflammatory
acne vulgaris,
ephelides (freckles),
and vascular lesions | Spot Size | 10 x 45mm &
8 x 34 mm | 8 x 40mm &
15 x 60mm | 12 x 33mm;
15 x 50mm &
15 x 35mm |
| Light
Source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | | | | |
| Wavelength | 430-1200nm | 530-1200nm | 430-1200nm | | | | |
| Delivery
System | Sapphire | Sapphire | Sapphire | | | | |
| Energy
Range | 10-60J/cm2 | 20-50J/cm2 | 10-60J/cm2 | | | | |
8
9
| Settings for Specific Indications for Use- Hair Reduction | |||
|---|---|---|---|
| Proposed Device | |||
| PlatinumGMT™ IPL | |||
| System (CLOUD) | Predicate Device | ||
| Multifunctional Series | |||
| (K131859) | Predicate Device | ||
| Intense Pulsed Light | |||
| (IPL) Systems | |||
| (K122995) | |||
| Wavelength | |||
| (mm) | 695 -1200 | 610-1200 | 640-1200 |
| Energy Range (J/cm2) | 10-60 | 20-50 | 10-44 |
| Pulse Duration (ms) | 9.9 | 13-15 | 3-14 |
| Pulse Delay (ms) | 1-99 | 15-35 | 16-32 |
| Spot Size | |||
| (mm) | 10 x 44 | 8 x 40 | |
| 15 x 60 | 12 x 33 | ||
| 15 × 50 | |||
| 15 x 35 |
| Settings for Specific Indications for Use- Treating Acne | |||
|---|---|---|---|
| Proposed Device | |||
| PlatinumGMT™ IPL | |||
| System (CLOUD) | Predicate Device | ||
| Multifunctional Series | |||
| (K131859) | Predicate Device | ||
| Intense Pulsed Light | |||
| (IPL) Systems | |||
| (K122995) | |||
| Wavelength | |||
| (mm) | 430-1200 | 530-1200 | 430-1200 |
| Energy Range | |||
| J/cm2 | 10-40 | 20-50 | 10-40 |
| Pulse Duration | |||
| (ms) | 3-8 | 3-10 | 3-8 |
| Pulse Delay | |||
| (ms) | 16-32 | 15-35 | 16-32 |
| Spot Size | |||
| (mm) | 8 × 34 | 8 × 40 | |
| 15 × 60 | 12 × 33 | ||
| 15 × 50 | |||
| 15 × 35 |
10
| Settings for Specific Indications for Use Vascular Lesions | |||
|---|---|---|---|
| Proposed Device | |||
| PlatinumGMT™ IPL | |||
| System (CLOUD) | Predicate Device | ||
| Multifunctional Series | |||
| (K131859) | Predicate Device | ||
| Intense Pulsed Light | |||
| (IPL) Systems | |||
| (K122995) | |||
| Wavelength | |||
| (mm) | 560-1200 | 585-1200 | 530-1200 |
| Energy Range | |||
| J/cm2 | 10-50 | 20-50 | 10-42 |
| Pulse Duration | |||
| (ms) | 9.9 | 3-10 | 3-8 |
| Pulse Delay | |||
| (ms) | 16-32 | 15-35 | 16-32 |
| Spot Size | |||
| (mm) | 8 x 34 | 8 x 40 | |
| 15 x 60 | 12 x 33 | ||
| 15 x 50 | |||
| 15 x 35 |
| Settings for Specific Indications for Use Pigmented Lesions | |||
|---|---|---|---|
| Proposed Device | |||
| PlatinumGMT™ IPL | |||
| System (CLOUD) | Predicate Device | ||
| Multifunctional Series | |||
| (K131859) | Predicate Device | ||
| Intense Pulsed Light | |||
| (IPL) Systems | |||
| (K122995) | |||
| Wavelength (mm) | 560-1200 | Not cleared | 480-1200 |
| Energy Range J/cm2 | 12-44 | Not cleared | 12-44 |
| Pulse Duration (ms) | 3-9 | Not cleared | 3-9 |
| Pulse Delay (ms) | 16-32 | Not cleared | 16-32 |
| Spot Size (mm) | 8 × 34 | Not cleared | 12 × 33 |
| 15 × 50 | |||
| 15 × 35 |