(60 days)
Not Found
No
The device description focuses on the physical components and laser technology, with no mention of AI or ML. The control unit is described as microprocessor-based, which is standard for medical devices and does not imply AI/ML.
Yes.
The device's intended uses, such as "treatment of melasma," "treatment of pigmented lesions," "treatment of vascular lesions," "skin resurfacing procedures for the treatment of acne scars and wrinkles," "removal of unwanted hair for stable long-term or permanent hair reduction and treatment of PFB," "photocoagulation and hemostasis of pigmented and vascular lesions," and "treatment of wrinkles," clearly indicate that it is used to treat or alleviate diseases/conditions, which falls under the definition of a therapeutic device.
No
The device is described as a laser system intended for various dermatological and cosmetic procedures such as incision, excision, ablation, vaporization of soft tissue, hair removal, treatment of melasma, pigmented lesions, acne scars, wrinkles, and tattoo removal. These are all therapeutic or cosmetic applications, not diagnostic ones.
No
The device description clearly outlines hardware components such as a high voltage power supply, cooling system, laser head (Nd:YAG and Ti:Sapphire), and a microprocessor-based controller unit. These are physical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The description clearly states that this device is a laser system (Q-switched Nd:YAG Laser and Ti:Sapphire Laser) used for various dermatological and cosmetic procedures performed on the patient's body. These procedures involve direct interaction with soft tissue and skin.
- Intended Use: The listed indications for use are all procedures performed directly on the patient, such as incision, excision, hair removal, treatment of lesions, skin resurfacing, and tattoo removal. None of these involve testing samples taken from the body.
Therefore, the HELIOS 785 Pico Laser System is a therapeutic and cosmetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
[Indications for use of Q-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
- port wine birthmarks
- telangiectaias
- spider angioma
- cherry angioma
- spider nevi
- Treatment of Pigmented Lesions
café-au-lait birthmarks solar lentiginos senile lentiginos becker's nevi freckles
nevus spilus - Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
light ink: red, sky blue, green, tan, purple, and orange
[Indications for use of FR mode in Nd:YAG Laser]
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
[Indications for use of Ti:Sapphire Laser]
785nm:
- Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The HELIOS 785 Pico is a laser system capable of emitting 1064nm, 532nm, and 785nm laser light selectively by switching wavelength conversion optical modules. It uses a flash lamp as a laser pumping source to convert electrical energy to light energy. The Nd:YAG crystal, with a specific resonator, emits a 1064nm laser by absorbing light energy from the flash lamp. A Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with a short pulse width of about 10ns. The amplified Q-switched 1064nm laser is secondarily amplified by another Nd:YAG crystal and then converted to a second harmonic 532nm laser by passing through a KTP crystal. Finally, a 785nm laser is emitted by the 785nm cavity with a Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
The device can operate in Q-switch mode, which normally produces polarized light. It can also operate in FR (Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP (Real Twin Pulse) mode can generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply.
b) A cooling system with an internal water flow circuit and a water-to-air heat exchanger.
c) A microprocessor-based controller unit for regulating functions and parameter selection.
d) The Nd:YAG laser + Ti:Sapphire laser head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin
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)
Non-clinical tests: Performance, such as safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:
- Basic safety and essential performance is tested and evaluated according to the -FDA-recognized consensus standard, ES 60601-1.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
- Safety of laser product is evaluated in accordance with IEC 60825-1: 2014.
- Risk management was recorded by referring to ISO 14971.
- Usability was documented by referring to IEC 60601-1-6.
- Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment is evaluated in accordance with IEC 60601-2-22.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2025
Laseroptek Co., Ltd. % Kim Do Hyun CEO BT Solutions, Inc. Unit 303, Gonghang-daero 337, Gangseo-gu Seoul, Seoul 07590 Korea, South
Re: K243780
Trade/Device Name: HELIOS 785 Pico (1754V2) 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: GEX Dated: December 9, 2024 Received: December 9, 2024
Dear Kim Do Hyun:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Digitally signed by TANISHA - Digitally signed by L. HITHE -> 22:25:46 -05'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K243780
Device Name HELIOS 785 Pico (1754V2)
Indications for Use (Describe)
[Indications for use of O-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- · nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
- · port wine birthmarks
- · telangiectaias
- · spider angioma
- · cherry angioma
- · spider nevi
- Treatment of Pigmented Lesions
- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- · freckles
- nevus spilus
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- · light ink: red, sky blue, green, tan, purple, and orange
[Indications for use of FR mode in Nd:YAG Laser]
-
Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
-
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
-
Coagulation and hemostasis of soft tissue
-
Treatment of wrinkles
-
[Indications for use of Ti:Sapphire Laser]
-
Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
785nm:
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
4
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary K243780
1 General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | Hyundai I Valley 114,116,117,203,204, 31, |
| Galmachi-ro 244beon-gil, Jungwon-gu, | |
| Seongnam-si, Gyeonggi-do, Republic of | |
| Korea | |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 303, Gonghang-daero 337, Gangseo-gu |
| Seoul, 07590, Republic of Korea | |
| Tel: +82-2-538-9140 | |
| Email: ceo@btsolutions.co.kr | |
| Preparation Date: | February 4, 2025 |
2 Device Name and Code
| Device Trade Name: | HELIOS 785 Pico |
|---|---|
| Model Name: | 1754V2 |
| Common Name: | Q-switched Nd:YAG + Gain switched |
| Ti:sapphire Laser System | |
| Classification Name: | Powered laser surgical instrument |
| Product Code: | GEX |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3 Technical Characteristics in Comparison to Predicate Devices
The HELIOS 785 Pico, is substantially equivalent to the following legally marketed predicate devices: HELIOS 785 Pico (1754V1) (K230373) and Finebeam (K202288);
| Predicate Device (1) | Proposed Device | |
|---|---|---|
| 510(K) Number | K230373 | K243780 |
| Product Code | GEX | GEX |
| Classification / | ||
| Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. |
Table 1 Comparison of the proposed device to the primary predicate device
6
HELIOS 785 Pico(Model: 1754V2) 510(k) Summary K243780
| Device Name | HELIOS 785 Pico | HELIOS 785 Pico |
|---|---|---|
| Model No. | 1754V1 | 1754V2 |
| Intended Use / | ||
| Indications for | ||
| Use: | [Indication for use of Q-switched | |
| Nd:YAG Laser] |
- Incision, excision, ablation,
vaporization of soft tissue for
general dermatology (1064nm) - Removal or lightening of
unwanted hair with or without
adjuvant preparation (1064nm) - Tattoo Removal (1064nm,
532nm)
dark ink: blue and black
(1064nm)
light ink: red, sky blue, green
(532nm) - Treatment of Vascular Lesions
(532nm)
port wine birthmarks
telangiectaias
spider angioma
cherry angioma
spider nevi - Treatment of Pigmented Lesions
(1064nm, 532nm)
café-au-lait birthmarks (532nm)
solar lentiginos (532nm)
senile lentiginos (532nm)
becker's nevi (532nm)
freckles (532nm)
nevus spilus (532nm)
nevus of ota (1064nm)
[Indication for use of Ti:Sapphire
Laser] - Removal of tattoos for
Fitzpatrick skin types II-IV to
treat the following tattoo colors:
green and blue. (785nm)
Q-switched Nd:YAG Laser and
Ti:Sapphire Laser cannot be used
simultaneously. | [Indications for use of Q-switched
Nd:YAG Laser]
1064 nm(including RTP 1064
mode): - Incision, excision, ablation,
vaporization of soft tissue for
general dermatology - Removal or lightening of
unwanted hair with or without
adjuvant preparation - Treatment melasma
- Treatment of Pigmented Lesions
nevus of ota - Skin resurfacing procedures for
the treatment of acne scars and
wrinkles - Tattoo Removal
dark ink: black, blue and brown
532 nm: - Treatment of Vascular Lesions
port wine birthmarks
telangiectaias
spider angioma
cherry angioma
spider nevi - Treatment of Pigmented Lesions
café-au-lait birthmarks
solar lentiginos
senile lentiginos
becker's nevi
freckles
nevus spilus - Skin resurfacing procedures for
the treatment of acne scars and
wrinkles - Tattoo Removal
light ink: red, sky blue, green,
tan, purple, and orange |
| | | [Indications for use of FR mode
in Nd:YAG Laser] - Removal of unwanted hair, for
stable long term or permanent
hair reduction and treatment of
PFB (Pseudofolliculitis Barbae).
The laser is indicated for all skin
types, Fitzpatrick I-VI, including
tanned skin - Photocoagulation and
hemostasis of pigmented and
vascular lesions, such as but not
limited to port wine stains,
cherry angioma, Hemangiomas,
warts, telangiectasias, rosacea,
leg veins, and spider veins - Coagulation and hemostasis of
soft tissue - Treatment of wrinkles
[Indications for use of
Ti:Sapphire Laser]
785 nm:
- Removal of tattoos for
Fitzpatrick skin types II-IV to
treat the following tattoo colors:
green and blue.
Q-switched Nd:YAG Laser and
Ti:Sapphire Laser cannot be used
simultaneously. |
| Wavelength | 1064 mm, 532 mm, 785 mm | 1064 mm, 532 mm, 785 mm |
| Pulse Duration
(max) | 5-10 ns @ 1064 nm
5-10 ns @ 532 nm
600 ps @ 785 nm | 5-10 ns @ 1064 nm
5-10 ns @ 532 nm
600 ps @ 785 nm
5-10 ns @ RTP mode(1064nm)5)
300 us @ FR mode(1064 nm)5) |
| Pulse Energy
(max) | 1.4 J @ 1064 nm
0.5 J @ 532 nm
0.2 J @ 785 nm | 1.4 J @ 1064 nm
0.5 J @ 532 nm
0.2 J @ 785 nm
2.0 J @ RTP mode(1064 nm)5)
3.0 J @ FR mode(1064 nm)5) |
| Spot size (mm) | - Zoom Collimator (1064, 532 nm) | - Zoom Collimator (1064, 532 nm) |
| | 110 mm | 510 mm |
| | - Zoom (1064, 532 nm) | - Zoom (1064, 532 nm) |
| | 17 mm | 17 mm |
| | - 1064 FX | - 1064 FX |
| | 5 mm x 5 mm | 5 mm x 5 mm |
| | - 532 FX | - 532 FX |
| | 4 mm x 4 mm | 4 mm x 4 mm |
| | - DIA FX 785 (785 nm) | - DIA FX 785 (785 nm) |
| | 8 mm x 8 mm | 8 mm x 8 mm |
| | - DIA FX 785 (785 nm) | - DIA FX 785 (785 nm) |
| | 5 mm x 5 mm | 5 mm x 5 mm |
| | - 785 Zoom (785 nm) | - 785 Zoom (785 nm) |
| | 1 mm x 1 mm ~ 7 mm x 7 mm | 1 mm x 1 mm ~ 7 mm x 7 mm |
| | - 785 Colimator (785 nm) | - 785 Colimator (785 nm) |
| | 7 mm x 7 mm | 7 mm x 7 mm |
| Repetition Rate (Hz) | 1-10 @ 1064 nm
1-10 @ 532 nm
1-10 @ 785 nm | 1-10 @ 1064 nm
1-10 @ 532 nm
1-10 @ 785 nm |
| Laser Type | Q-switched Nd:YAG and
Ti:sapphire | Q-switched Nd:YAG and
Ti:sapphire |
| Activation | Via foot-switch | Via foot-switch |
| Display | TFT LCD Touch screen | TFT LCD Touch screen |
| Electrical Power | 220-230 V~, 50/60 Hz | 220-230 V~, 50/60 Hz |
| Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece |
| System Dimensions (mm) | 936(H) x298(W) x 819(D) | 936(H) x298(W) x 819(D) |
| System Weight (kg) | 80 | 80 |
7
8
510(k) Summary
Table 2 Comparison of the proposed device to the secondary predicate device.
| Predicate Device(2) | Proposed Device | |
|---|---|---|
| 510(K) Number | K202288 | K243780 |
| Product Code | GEX | GEX |
| Classification / | ||
| Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | SNJ Co., Ltd. | Laseroptek Co.,Ltd. |
| Device Name | Finebeam | HELIOS 785 Pico |
9
| Model No. | - | 1754V2 | |||
|---|---|---|---|---|---|
| Intended Use / | |||||
| Indications for | |||||
| Use: | [532nm single and 1064nm single | ||||
| function in the Q-switched mode] | |||||
| With 1064nm single or 1064nm | |||||
| PDP function |
- Removal dark ink (black, blue
and brown) tattoos - Treatment melasma
- Treatment nevus of Ota
- Treatment common nevi
- Removal of lightening of
unwanted hair - Skin resurfacing procedures for
the treatment of acne scars and
wrinkles
With 532nm single function
- Removal of light ink (red, tan,
purple, and orange) tattoos - Treatment of vascular lesions
including, but not limited to
port-wine stains, telangiectasias,
spider angioma, cherry angioma - Treatment of pigmented lesions
including, but not limited to
cafe-au-Lait birthmarks, solar
lentigines, senile lentigines,
Becker's nevi, freckles, common
nevi, and nevus spilus - Treatment of seborrheic
keratosis - Treatment of post-inflammatory
hyperpigmentation - Skin resurfacing procedures for
the treatment of acne scars and
wrinkles
[Non-Q-Switched function in the
Q-Switched mode]
With 1064nm Non-QSW function
- Removal of unwanted hair, for
stable long term or permanent | [Indications for use of Q-switched
Nd:YAG Laser]
1064 nm(including RTP 1064
mode): - Incision, excision, ablation,
vaporization of soft tissue for
general dermatology - Removal or lightening of
unwanted hair with or without
adjuvant preparation - Treatment melasma
- Treatment of Pigmented Lesions
nevus of ota - Skin resurfacing procedures for
the treatment of acne scars and
wrinkles - Tattoo Removal
dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
port wine birthmarks
telangiectasias
spider angioma
cherry angioma
spider nevi - Treatment of Pigmented Lesions
café-au-Lait birthmarks
solar lentigines
senile lentigines
becker's nevi
freckles
nevus spilus - Skin resurfacing procedures for
the treatment of acne scars and
wrinkles - Tattoo Removal light ink: red, sky blue, green,
tan, purple, and orange | | hair reduction and treatment of
PFB (Pseudofolliculitis Barbae).
The laser is indicated for all skin
types, Fitzpatrick I-VI, including
tanned skin - Photocoagulation and
hemostasis of pigmented and
vascular lesions, such as but not
limited to port wine stains,
cherry angioma, Hemangiomas,
warts, telangiectasias, rosacea,
leg veins, and spider veins - Coagulation and hemostasis of
soft tissue - Treatment of wrinkles | [Indications for use of FR mode
in Nd:YAG Laser] - Removal of unwanted hair, for
stable long term or permanent
hair reduction and treatment of
PFB (Pseudofolliculitis Barbae).
The laser is indicated for all skin
types, Fitzpatrick I-VI, including
tanned skin - Photocoagulation and
hemostasis of pigmented and
vascular lesions, such as but not
limited to port wine stains,
cherry angioma, Hemangiomas,
warts, telangiectasias, rosacea,
leg veins, and spider veins - Coagulation and hemostasis of
soft tissue - Treatment of wrinkles
[Indications for use of
Ti:Sapphire Laser]
785 nm:
- Removal of tattoos for
Fitzpatrick skin types II-IV to
treat the following tattoo colors:
green and blue.
Q-switched Nd:YAG Laser and
Ti:Sapphire Laser cannot be
used simultaneously. |
| Wavelength | 1064 nm, 532 nm | 1064 nm, 532 nm, 785 nm | | | |
| Pulse Duration
(max) |