(436 days)
Not Found
No
The description focuses on the hardware components and basic control functions of a laser/IPL 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 intended to treat various medical conditions, including benign pigmented epidermal lesions, benign cutaneous vascular lesions, scars, inflammatory acne vulgaris, benign vascular lesions, pigmented lesions, and wrinkles. Additionally, it aids in hair reduction.
No
The device description and intended use outline the device's function for cosmetic and dermatological treatments using IPL and laser handpieces. There is no mention of the device collecting, analyzing, or interpreting data for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a power supply module, control module, display module, high current capacitors, cooling system, and laser generator, in addition to various handpieces. This indicates it is a hardware-based medical device with integrated software for control and display.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to treating conditions and performing procedures directly on the patient's body (dermatology, cosmetic surgery, hair reduction, lesion treatment, wrinkle treatment, etc.). IVDs 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 delivers light and laser energy to the patient. It includes components like a power supply, control module, display, capacitors, cooling system, and laser generator. These are typical components of therapeutic or surgical devices, not diagnostic devices that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the processes associated with in vitro diagnostics.
The device is clearly intended for therapeutic and cosmetic applications performed directly on the patient.
N/A
Intended Use / Indications for Use
The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.
(1) IPL Handpiece
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
- Moderate inflammatory acne vulgaris;
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- Cutaneous lesions including scars;
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
(2) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):
- Benign vascular and pigmented lesions, age spots:
- Nevus spilus:
- Tattoo removal.
(3) Long pulsed Nd:YAG Handpiece:
- Benign vascular lesions
- Superficial and deep telangiectasias (venulectasias)
- Benign cutaneous lesions
- Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- The non-ablative treatment of facial wrinkles
- Laser skin resurfacing procedures
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
- Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
- Removal or lightening of unwanted hair (with and without adjuvant preparation)
- Treatment of pseudofolliculitis barbae (PFB)
Product codes
ONF, GEX
Device Description
The proposed device, Platform Treatment System, HS-900K can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. These five handpieces are (1) Intense Pulsed Light (IPL) Handpiece, (2) Q-switched Nd:YAG laser Handpiece and (3) Long pulsed Nd:YAG Handpiece. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use.
The main unit consists of:
- (1) The Power supply module: Controls electrical supply to the entire system.
- (2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
- a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
- b) Emergency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
- c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system status is displayed on the screen.
- (3) The display module: Displays various information of the system and accept users' instruction.
- (4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
- (5) Cooling system: Maintains a stable thermal environment for optimum performance.
- (6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.
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)
A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-2-57: 2011 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
January 28, 2022
Shanghai Apolo Medical Technology Co., Ltd. Felix Li RA Supervisor Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai, Shanghai 200231 China
Re: K203395
Trade/Device Name: Platform treatment system 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, GEX Dated: October 21, 2021 Received: November 1, 2021
Dear Felix Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203395
Device Name Platform Treatment System
Indications for Use (Describe)
The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.
(1) IPL Handpiece
-
Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
-
Moderate inflammatory acne vulgaris;
-
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
-
Cutaneous lesions including scars;
-
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
(2) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):
- Benign vascular and pigmented lesions, age spots:
- Nevus spilus:
- Tattoo removal.
(3) Long pulsed Nd:YAG Handpiece:
-
Benign vascular lesions
-
Superficial and deep telangiectasias (venulectasias)
-
Benign cutaneous lesions
-
Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
-
The non-ablative treatment of facial wrinkles
-
Laser skin resurfacing procedures
-
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
-
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
-
Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
-
Removal or lightening of unwanted hair (with and without adjuvant preparation)
-
Treatment of pseudofolliculitis barbae (PFB)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (7/17)
3
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4
510(k) summary
l Submitter
Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District, 200231, Shanghai China
Establishment Registration Number: 3007120647
Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn
Date of preparation: Jan 27th, 2022.
II Proposed Device
| Trade Name of Device: | Platform Treatment System |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | GEX |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K200746 |
|---|---|
| Trade name: | IPL Treatment System |
| Common name: | Low Level Laser System for Aesthetic Use |
| Classification: | Class II |
| Product Code: | ONF |
| Manufacturer | Shanghai Apolo Medical Technology Co., Ltd. |
| 510(k) Number: | K192856 |
|---|---|
| Trade name: | MT One |
5
| Common name: | Powered Laser Surgical Instrument |
|---|---|
| Classification: | Class II |
| Product Code: | GEX, ONG, ONF, ONE |
| Manufacturer | M&T SRL |
| 510(k) Number: | K072564 |
| Trade name: | Harmony XL Multi-Application Platform and Thermoelectric Cooler |
| Common name: | Powered Laser Surgical Instrument |
| Classification: | Class II |
| Product Code: | GEX, FTC, HHR, LNK |
| Manufacturer | Alma Lasers, Ltd. |
IV Device description
The proposed device, Platform Treatment System, HS-900K can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. These five handpieces are (1) Intense Pulsed Light (IPL) Handpiece, (2) Q-switched Nd:YAG laser Handpiece and (3) Long pulsed Nd:YAG Handpiece. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use.
The main unit consists of:
- (1) The Power supply module: Controls electrical supply to the entire system.
- (2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
- a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
- b) Emerqency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
- c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system
6
status is displayed on the screen.
- (3) The display module: Displays various information of the system and accept users' instruction.
- (4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
- (5) Cooling system: Maintains a stable thermal environment for optimum performance.
- (6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.
V Indication for use
The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.
(1) IPL Handpiece
-
Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
-
Moderate inflammatory acne vulgaris;
-
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
-
Cutaneous lesions including scars;
-
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias,
erythema of rosacea, leq veins, spider angiomas and venous malformations.
(2) Q-switched Nd:YAG laser Handpiece (1064nm wavelength):
- Benign vascular and pigmented lesions, age spots;
- Nevus spilus;
- Tattoo removal.
(3) Long pulsed Nd:YAG Handpiece:
- Benign vascular lesions
- Superficial and deep telangiectasias (venulectasias)
- Benign cutaneous lesions
- Pigmented lesions to reduce lesion size, for patients with lesions that would
7
potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
-
The non-ablative treatment of facial wrinkles
-
Laser skin resurfacing procedures
-
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
-
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
-
Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
-
Removal or lightening of unwanted hair (with and without adjuvant preparation)
-
Treatment of pseudofolliculitis barbae (PFB)
ltem Proposed device Predicate device Discussion (IPL Treatment System K200746) Indication for The Platform Treatment The IPL treatment Identical use System with IPL system is intended for handpiece is intended medical use in the for medical use in the treatment of the treatment of following dermatoloqic the following dermatologic conditions: conditions: - Permanent Permanent hair hair reduction - longreduction - long-term term stable reduction in stable reduction in number of hairs renumber of hairs regrowing after growing after a a treatment regimen; treatment regimen; -Moderate inflammatory Moderate acne vulgaris; - Benign inflammatory acne pigmented epidermal vulgaris; - Benign lesions including pigmented epidermal dyschromia, lesions including hyperpigmentation, dyschromia. melasma. ephelides hyperpigmentation. (freckles); - Cutaneous melasma, ephelides lesions including scars; (freckles): -Benign cutaneous Cutaneous lesions .
VI Comparison of technological characteristics with the predicate devices
8
| | vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. | including scars; -
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Light source | Intense pulsed light
(Xenon Flash Lamp) | Intense pulsed light
(Xenon Flash Lamp) | Identical |
| Wavelength range | 420 – 1200 nm | 420 – 1200 nm | Identical |
| Energy output | 4.1-50.8 J/cm² | 4.1-50.8 J/cm² | Identical |
| Pulse width | 5-20 ms | 5-20 ms | Identical |
| Pulse duration | 5-50 ms | 5-50 ms | Identical |
| Spot size | 1235mm, 1550mm | 1235mm, 1550mm | Identical |
| Filters | 420 -1200nm: Acne;
510 -1200nm: Acne,
vascular, pigment;
560 -1200nm: Acne,
vascular, pigment;
610-1200nm: Hair removal;
640-1200nm: Hair removal;
690-1200nm: Hair removal; | 420 -1200nm: Acne;
510 -1200nm: Acne,
vascular, pigment;
560 -1200nm: Acne,
vascular, pigment;
610-1200nm: Hair removal;
640-1200nm: Hair removal;
690-1200nm: Hair removal; | Identical |
| Fluences | 420 -1200nm: 4.1-
50.8J/ cm²;
510 -1200nm: 3.8-47 J/
cm²;
560 -1200nm: 3.7-43.3 J/ cm²; | 420 -1200nm: 4.1-
50.8J/ cm²;
510 -1200nm: 3.8-47 J/
cm²;
560 -1200nm: 3.7-43.3 J/ cm²; | Identical |
| | 610-1200nm: 3.5-38.7 J/ cm²;
640-1200nm: 3.3-37.4J/
cm²;
690-1200nm: 3.1-33.4J/
cm²; | 610-1200nm: 3.5-38.7 J/ cm²;
640-1200nm: 3.3-
37.4J/ cm²;
690-1200nm: 3.1-
33.4J/ cm²; | |
| Output
mode | Pulse mode | Pulse mode | Identical |
| Deliver
materials | Direct sapphire
Coupling | Direct sapphire
Coupling | Identical |
9
10
| Item | Proposed device | Predicate device
(MT ONE K192856) | Discussion |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for
use | The Platform Treatment
System with 532/1064
nm Nd:YAG Q-Switch
Laser Handpiece is
indicated for:
• Benign vascular and
pigmented lesions, age
spots;
• Nevus spilus;
• Tattoo removal. | The MT ONE with
532/1064 nm Nd:YAG
Q-Switch Laser
Handpiece is indicated
for:
• Benign vascular and
pigmented lesions,
age spots;
• Nevus spilus;
• Tattoo removal. | Identical |
| Wavelength
range | 532/1064 nm | 532/1064 nm | Identical |
| Energy
output | Max 1.2J (532nm)
Max 2.4J (1064nm) | 3.2 J/cm² (532nm)
Φ8mm
4 J/cm² (1064nm)
Φ8mm | Equivalent |
| Spot size | 1,2,3,4,5 mm | 1,2,3,4,5,8 mm | Equivalent |
| Frequency | 1 to 10 Hz | Up to 10 Hz | Identical |
| Pulse
duration | Port wine stains
Hemangiomas
Warts
• Superficial and deep telangiectasias (venulectasias)
Reticular veins (0.1-4.0 mm dia.) of the leg
Rosacea
Venus lake
Leg veins
Spider veins
Poikiloderma of Civatte
Angiomas
• Benign cutaneous lesions, such as, but not limited to:
Warts
Scars | Identical |
12
| keloid scars where
vascularity is an
integral part of the
scar. Indicated for use on
all skin types
(Fitzpatrick I-VI),
including tanned
skin. Removal of
unwanted hair, for
stable long-term, or
permanent, hair
reduction through
selective targeting
of melanin in hair
follicles. Removal or
lightening of
unwanted hair (with
and without
adjuvant
preparation) Treatment of
pseudofolliculitis
barbae (PFB) | Striae Psoriasis Solar lentigos (sun
spots) Cafd-au-lait
macules Seborrheic
keratoses Nevi and nevus of
Ota Chloasma Verrucae Skin tags Keratoses The removal of
black, blue or
green tattoos
(significant
reduction in the
intensity of black
and /or blue/black
tattoos). Plaques Pigmented lesions to
reduce lesion size, for
patients with lesions
that would potentially
benefit from
aggressive treatment,
and for patients with
lesions that have not
responded to other
laser treatments. The non-ablative
treatment of facial
wrinkles, such as, but
not limited to: Periocular
wrinkles Perioral wrinkles | | Laser skin
resurfacing
procedures for the
treatment of: Acne scars Wrinkles Reduction of red
pigmentation in
hypertrophic and
keloid scars where
vascularity is an
integral part of the
scar. Indicated for use on
all skin types
(Fitzpatrick I-VI),
including tanned skin. The 1064 nm Nd:YAG
lasers (Long Pulsed
only, with and without
contact-cooling) is
indicated for: Removal of
unwanted hair, for
stable long-term, or
permanent, hair
reduction through
selective targeting of
melanin in hair
follicles. Removal or
lightening of unwanted
hair (with and without
adjuvant preparation) Treatment of
pseudofolliculitis
barbae (PFB) |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
13
14
| Wavelength range | 1064 nm | 1064 nm | Identical |
|---|---|---|---|
| Fluence | 10 ~ 500 J/ cm² | Up to 30 ~ 450J/ cm² | Equivalent |
| Spot size | 2.2x5mm, ¢6mm, ¢ 9mm | 2,6,10mm | Equivalent |
| Frequency | 1 Hz | 1 Hz | Equivalent |
| Pulse duration | 10 ~ 40ms | 10, 12, 15, 45ms | Equivalent |
| Deliver materials | Aluminum alloy | Aluminum alloy | Identical |
15
VII Non-Clinical Testing
A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical ● IEC electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and ● requirements
- IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-2-57: 2011 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
VIII Clinical Testing
lt is not applicable.