Who is the manufacturer of CLARITY LPC LASER SYSTEM?

Lutronic Corporation filed the 510(k) submission for CLARITY LPC LASER SYSTEM (K130199).

What is the FDA product code for CLARITY LPC LASER SYSTEM?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for CLARITY LPC LASER SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CLARITY LPC LASER SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CLARITY LPC LASER SYSTEM

K130199 · Lutronic Corporation · GEX · Nov 22, 2013 · General, Plastic Surgery

Device Facts

Record ID	K130199
Device Name	CLARITY LPC LASER SYSTEM
Applicant	Lutronic Corporation
Product Code	GEX · General, Plastic Surgery
Decision Date	Nov 22, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. 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 regime. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on 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, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Device Story

Dual-wavelength laser system (755 nm Alexandrite and 1064 nm Nd:YAG) for dermatological procedures. Device uses optical fiber delivery to a handpiece to produce circular beams (2-20 mm). Includes Intelligent Cooling Device (ICD) for skin protection. Operated by clinicians in a clinical setting via LCD touch screen to select fluence, pulse duration (0.35-300 ms), and repetition rate (up to 10 Hz). Triggered by finger or footswitch. Provides photocoagulation, hemostasis, and selective melanin targeting to reduce hair, vascular lesions, and pigmented lesions. Benefits include permanent hair reduction and lesion size reduction.

Clinical Evidence

No clinical data presented; substantial equivalence is based on technological characteristics and performance parameters compared to the predicate device.

Technological Characteristics

Dual-resonator laser (Alexandrite 755 nm, Nd:YAG 1064 nm). Pulse duration 0.35-300 ms; repetition rate up to 10 Hz. Spot sizes 2-20 mm. Includes Intelligent Cooling Device (ICD). Delivery via optical fiber and handpiece. Touch screen interface for parameter control.

Indications for Use

Indicated for hair removal/reduction, treatment of PFB, benign pigmented lesions, vascular lesions, soft tissue coagulation/hemostasis, and wrinkles in patients of all Fitzpatrick skin types (I-VI), including tanned skin.

Regulatory Classification

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.

Predicate Devices

Candela Corporation GentleMAX Family of Laser Systems (K112715)

Related Devices

K112715 — CANDELA GENTLEMAX FAMILY OF LASERS · Candela Corp. · Oct 5, 2011
K181486 — DEKA Motus AY · El.En Electronic Engineering Spa · Aug 30, 2018
K063074 — CANDELA 3630 LASER SYSTEM · Candela Corp. · Dec 27, 2006
K201111 — GentleMax Pro Plus · Candela Corporation · May 26, 2020
K160227 — ACCENTO / HWA Dual/Single laser · Bison Medical Co, Ltd. · Apr 22, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ KI30199 NOV 2 2 2013 Page I of II ## 510(k) Summary for the Lutronic Corporation CLARITY LPC Laser System This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92. ## 1. General Information Submitter: Lutronic Corporation 219 Sowon-ro Haengsin-dong, Deogyang-gu Goyang-si, Gyeonggi-do 410-722 Republic of Korea Tel: (82) 31-908-3440 Fax: (82) 31-907-3440 Jhung Won Vojir, Ph.D Preparer and Contact Person: Global Regulatory Officer Lutronic, Inc. Six Neshaminy Interplex, Suite 100 Trevose, PA 19053 Telephone: 215-205-2219 Fax: 609-488-6958 October 21, 2013 Summary Preparation Date: 2. Names CLARITY LPC Laser System Trade Name: Common Name: Dermatology Laser Laser Instrument, Surgical, Powered Classification Name: Product Code: GEX Panel: General & Plastic Surgery Regulatory Class: II Regulation Number: 21 CFR 878.4810 ## 3. Predicate Devices The CLARITY LPC Laser System is substantially equivalent to the Candela Corporation GentleMAX Family of Laser Systems (K112715). {1}------------------------------------------------ ## 4. Device Description The CLARITY LPC Laser System contains two separate laser resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device. The CLARITY LPC laser system is configured with an ICD (Intelligent Cooling Device) skin cooling device. The CLARITY LPC Laser System delivers laser energy with various pulse durations from 0.35 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (finger switch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration). The laser output energy is delivered via an optical fiber to a handpiece which produces circular beams with diameters from 2 to 20 millimeters on the skin. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system. ## 5. Indications for Use The CLARITY LPC Laser System is indicated for the following: ## 755mm The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. 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 regime. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). {2}------------------------------------------------ ## l 064nm The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on 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, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. ## 6. Substantial Equivalence The CLARITY LPC Laser System is substantially equivalent to the GentleMAX Family of Laser Systems cleared in K112715. The CLARITY LPC Laser System has the same technological characteristics as the predicate device. Both devices have two separate laser resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength of 755 nm and of 1064 nm, respectively. Additionally, they have the same intended uses, similar treatment parameters, similar operating principles, including similar spot sizes and the same maximum delivered fluence as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, CLARITY LPC Laser System is substantially equivalent to the predicate device. {3}------------------------------------------------ ## Page 4 of 11 : 1 | Device | CLARITY-LPC Laser System | GentleMAX Family of Laser Systems | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Lutronic Corporation | Candela Corporation | | 510(k) # | K130199 | K112715 | | Wavelength | 755 nm | 755 nm | | Laser Source | Alexandrite | Alexandrite | | Indication | The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. 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 regime. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias) | The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick 1-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias) | {4}------------------------------------------------ | Page | 5 | of | 11 | |------|---|----|----| |------|---|----|----| . | | Skin Type | Pulse Duration | Spot Size | Fluence | Skin Type | Pulse Duration | Spot Size | Fluence | | | | | | | | | |-----------------------------------------------------|-----------------------------------------------------------------------------|----------------|-----------|-------------|-----------|-----------------------------------------------------------------------------|-------------|-------------|-------------|-----------------------------------------------------|--|--|--|--|--|--| | | I – II | 3 ms | 8 mm | 30-40 J/cm² | I – II | 3 ms | 8 mm | 30-40 J/cm² | | | | | | | | | | | | 3 ms | 10 mm | 26-34 J/cm² | | 3 ms | 10 mm | 25-35 J/cm² | | | | | | | | | | | | 3 ms | 12 mm | 26-30 J/cm² | | 3 ms | 12 mm | 26-36 J/cm² | | | | | | | | | | | | | | 3 ms | | 15 mm | 20-40 J/cm² | | | | | | | | | | | | | | | 3 ms | | 18 mm | 14-20 J/cm² | | | | | | | | | | | | III | 3 ms | 8 mm | 26-40 J/cm² | | 3 ms | 8 mm | 25-40 J/cm² | | | | | | | | | | | | 3 ms | 10 mm | 15-30 J/cm² | | 3 ms | 10 mm | 15-30 J/cm² | | | | | | | | | | | | 3 ms | 12 mm | 18-26 J/cm² | III | 3 ms | 12 mm | 18-30 J/cm² | | | | | | | | | | Treatment Parameters for hair removal | | 3 ms | 15 mm | 16-19 J/cm² | | 3 ms | 15 mm | 16-25 J/cm² | | | | | | | | | | | | 3 ms | 18 mm | 10-13 J/cm² | | 3 ms | 18 mm | 10-16 J/cm² | | | | | | | | | | | IV | 3 ms | 8 mm | 20-30 J/cm² | | | 3 ms | 8 mm | 20-30 J/cm² | | | | | | | | | | | 3 ms | 10 mm | 15-24 J/cm² | | | 3 ms | 10 mm | 15-25 J/cm² | | | | | | | | | | | 3 ms | 12 mm | 16-20 J/cm² | IV | 3 ms | 12 mm | 16-20 J/cm² | | | | | | | | | | | | 3 ms | 15 mm | 10-15 J/cm² | | 3 ms | 15 mm | 10-20 J/cm² | | | | | | | | | | | | 3 ms | 18 mm | 8-11 J/cm² | | 3 ms | 18 mm | 8-16 J/cm² | | | | | | | | | | | V | 3 ms | 8 mm | 20-24 J/cm² | | | 3 ms | 8 mm | 20-25 J/cm² | | | | | | | | | | | 3 ms | 10 mm | 16-20 J/cm² | | | 3 ms | 10 mm | 16-20 J/cm² | | | | | | | | | | | 3 ms | 12 mm | 14-20 J/cm² | V | 3 ms | 12 mm | 14-20 J/cm² | | | | | | | | | | | | 3 ms | 15 mm | 10-15 J/cm² | | 3 ms | 15 mm | 10-20 J/cm² | | | | | | | | | | | | 3 ms | 18 mm | 6-11 J/cm² | | 3 ms | 18 mm | 6-16 J/cm² | | | | | | | | | | | VI | 3 ms | 8 mm | 20-24 J/cm² | | | 3 ms | 8 mm | 20-25 J/cm² | | | | | | | | | | | 3 ms | 10 mm | 16-20 J/cm² | | | 3 ms | 10 mm | 16-20 J/cm² | | | | | | | | | | | 3 ms | 12 mm | 10-20 J/cm² | VI | 3 ms | 12 mm | 10-20 J/cm² | | | | | | | | | | | | 3 ms | 15 mm | 6-13 J/cm² | | 3 ms | 15 mm | 6-20 J/cm² | | | | | | | | | | | | 3 ms | 18 mm | 6-10 J/cm² | | 3 ms | 18 mm | 6-16 J/cm² | | | | | | | | | | | Skin Type I – IV (solar lentigines, benign melanocytic nevi) | 3 ms | 8 mm | 30-40 J/cm² | | Skin Type I – IV (solar lentigines, benign melanocytic nevi) | 3 ms | 8 mm | 30-40 J/cm² | Treatment Parameters for pigmented lesions | | | | | | | | | Skin Type I – IV (solar lentigines, benign melanocytic nevi) | 3 ms | 8 mm | 30-40 J/cm² | | Skin Type I – IV (solar lentigines, benign melanocytic nevi) | 3 ms | 8 mm | 30-40 J/cm² | | | | | | | | | Treatment Parameters for pigmented lesions | | | | | | | | | | | | | | | | | and the comments of the comments of the country of {5}------------------------------------------------ # Page 6 of 1 I ﻟ | | I – IV (Seborrheic keratoses) | 3 ms | 10 mm | 30-40 J/cm² | I – IV (seborrheic keratoses) | 3 ms | 10 mm | 80-100 J/cm² | |-----------------------------------------|-------------------------------------------|----------------|--------------|-------------|-------------------------------------------|----------------|-----------|--------------| | | 3 ms | 12 mm | 80-100 J/cm² | | 3 ms | 12 mm | | | | | Skin Type | Pulse Duration | Spot Size | Fluence | Skin Type | Pulse Duration | Spot Size | Fluence | | Treatment Parameters for wrinkles | I - IV | 3 ms | 12 mm | 26-30 J/cm² | I – IV | 3 ms | 12 mm | 25-40 J/cm² | | Fluence | Max 600 J/cm² | | | | 520 J/cm² | | | | | Pulse Width | 0.35 ms to 300 ms | | | | 0.25 ms to 300 ms | | | | | Average Power (Watts) | 55.95 W | | | | 50.84 W | | | | | Maximum Energy Delivered (J) | Max 55.95 J (Pulse width: 300 ms @ 18 mm) | | | | Max 50.87 J (Pulse width: 300 ms @ 18 mm) | | | | | Pulse Rate | Up to 10 Hz | | | | Up to 10 Hz | | | | | Spot Size | 2, 3, 5, 8, 10, 12, 15, 18, 20 mm | | | | 6, 8, 10, 12, 15, and 18 mm | | | | | Delivery System | Optical fiber with handpiece | | | | Optical fiber with handpiece | | | | | Cooling | Water to Air | | | | Water to Air | | | | {6}------------------------------------------------ # Page 7 of 11 i, ## Predicate Comparison Table for 1064nm | Device | CLARITY LPC Laser-System | GentleMAX Family of Laser Systems | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Lutronic Corporation | Candela Corporation | | 510(k) # | K130199 | K112715. | | Wavelength | 1064 nm | 1064 nm | | Laser Source | Nd: YAG | Nd: YAG | | Indications | The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on 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, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would | The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicated on 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. hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to. lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. | {7}------------------------------------------------ | potentially benefit from aggressive treatment, and for | | | | Treatment of wrinkles. | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|--------------|------------------------|----------------|-----------|--------------| | patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. | | | | | | | | | Skin Type | Pulse Duration | Spot Size | Fluence | Skin Type | Pulse Duration | Spot Size | Fluence | | I - II | 20 ms | 8 mm | 90-100 J/cm2 | I - II | 3, 10, 20 ms | 8 mm | 90-100 J/cm2 | | | | 10 mm | 70-80 J/cm2 | | | 10 mm | 70-80 J/cm2 | | | | 12 mm | 60-70 J/cm2 | | | 12 mm | 60-70 J/cm2 | | | | 15 mm | 40-44 J/cm2 | | | 15 mm | 40-44 J/cm2 | | | | 18 mm | 26-30 J/cm2 | | | 18 mm | 26-30 J/cm2 | | III | 20 ms | 8 mm | 80-90 J/cm2 | III | 3, 10, 20 ms | 8 mm | 80-90 J/cm2 | | | | 10 mm | 50-70 J/cm2 | | | 10 mm | 50-70 J/cm2 | | | | 12 mm | 40-60 J/cm2 | | | 12 mm | 40-60 J/cm2 | | | | 15 mm | 30-40 J/cm2 | | | 15 mm | 30-40 J/cm2 | | | | 18 mm | 24-30 J/cm2 | | | 18 mm | 24-30 J/cm2 | | IV | 20 ms | 8 mm | 60-70 J/cm2 | IV | 3, 10, 20 ms | 8 mm | 60-70 J/cm2 | | | | 10 mm | 40-50 J/cm2 | | | 10 mm | 40-50 J/cm2 | | | | 12 mm | 20-45 J/cm2 | | | 12 mm | 20-46 J/cm2 | | | | 15 mm | 20-30 J/cm2 | | | 15 mm | 20-30 J/cm2 | | | | 18 mm | 14-20 J/cm2 | | | 18 mm | 14-20 J/cm2 | | V | 20 ms | 8 mm | 50-60 J/cm2 | V | 3, 10, 20 ms | 8 mm | 50-60 J/cm2 | | | | 10 mm | 30-50 J/cm2 | | | 10 mm | 30-50 J/cm2 | | | | 12 mm | 18-30 J/cm2 | | | 12 mm | 18-30 J/cm2 | | | | 15 mm | 10-30 J/cm2 | | | 15 mm | 10-30 J/cm2 | | | | 18 mm | 6-20 J/cm2 | | | 18 mm | 6-20 J/cm2 | | VI | 20 ms | 8 mm | 40-50 J/cm2 | VI | 3, 10, 20 ms | 8 mm | 40-50 J/cm2 | | | | 10 mm | 30-40 J/cm2 | | | 10 mm | 30-40 J/cm2 | | | | 12 mm | 18-30 J/cm2 | | | 12 mm | 18-30 J/cm2 | | | | 15 mm | 6-30 J/cm2 | | | 15 mm | 6-30 J/cm2 | | | | 18 mm | 6-20 J/cm2 | | | 18 mm | 6-18 J/cm2 | # Page 8 of 11 {8}------------------------------------------------ #### Page 9 of 11 | | Lesion | Pulse Duration | Spot Size | Fluence | Lesion | Pulse Duration | Spot Size | Fluence | |-----------------------------------------------------|--------------------------------------------------|----------------|-----------|-------------------------|--------------------------------------------------|----------------|-----------|-------------------------| | Treatment Parameters for pigmented lesions | Telangiectasia < 1 mm | 40-50 ms | 3 mm | Start with 220 J/cm² | Telangiectasia < 1 mm | 40-60 ms | 3 mm | Start with 220 J/cm² | | | Telangiectasia (Facial) Vessels < 1 mm | 30 ms | 3 mm | Start with 130 J/cm² | Telangiectasia (Facial) Vessels < 1 mm | 30 ms | 3 mm | Start with 130 J/cm² | | | Telangiectasia (Leg) Vessels < 1.5 mm | 40-50 ms | 3 mm | Start with 200 J/cm² | Telangiectasia (Leg) Vessels < 1.5 mm | 40-60 ms | 3 mm | Start with 200 J/cm² | | | Telangiectasia (Leg) Vessels 1.5-3.0 mm | 50 ms | 3 mm | Start with 180 J/cm² | Telangiectasia (Leg) Vessels 1.5-3.0 mm | 60 ms | 3 mm | Start with 180 J/cm² | | | Area | Pulse Duration | Spot Size | Fluence | Area | Pulse Duration | Spot Size | Fluence | | Treatment Parameters for wrinkles | Face & Neck | 50 ms | 10 mm | 50 J/cm² | Face & Neck | 50 ms | 10 mm | 50 J/cm² | | | Forehead | 50 ms | 10 mm | 40-50 J/cm² | Forehead | 50 ms | 10 mm | 40-50 J/cm² | | Fluence | Max. 600 J/cm² | | | | Max. 600 J/cm² | | | | | Pulse Width | 0.35 ms to 300 ms | | | | 0.25 ms to 300 ms | | | | | Average Power (Watts) | 96.08 W | | | | 76.30 W | | | | | Maximum Energy Delivered (J) | Max 96.08 J (Pulse width: 300 ms @ 18 mm) | | | | Max 76.30 J (Pulse width: 300 ms @ 18 mm) | | | | | Pulse Rate | Up to 10 Hz | | | | Up to 10 Hz | | | | · · ﺘﺮ {9}------------------------------------------------ # Page 10 of 11 . ﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | Spot Size | 2, 3, 5, 8, 10, 12, 15, 18, 20 mm | 1.5, 3, 6, 8, 10, 12, 15, and 18mm | |--------------------|-----------------------------------|------------------------------------| | Delivery System | Optical fiber with handpiece | Optical fiber with handpiece | | Cooling | Water to Air | Water to Air | . . . ・ . · . . {10}------------------------------------------------ . 7. Performance Data None presented. ﺀ ﺴﺴ {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Lutronic Corporation Jhung Won Voiir, M.S. Ph.D. Global Regulatory Officer 6 Neshaminy Interplex, Suite 100 Trevose, Pennsylvania 19053 November 22, 2013 Re: K130199 Trade/Device Name: CLARITY LPC Laser 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: GEX Dated: October 18, 2013 Received: October 18, 2013 Dear Dr. Vojir: 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 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 {12}------------------------------------------------ Page 2 - Jhung Won Vojir 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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, # Joshual@Nipper -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {13}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K130199 Device Name: CLARITY LPC Laser System #### Indications for Use: #### 755mm The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable longterm or permanent reduction through selective targeting of melanin in hair follicles. 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 regime. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). #### 1064nm The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on 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, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over The Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page I of 1 Neil R Oaden 2013.11 22 09:1 00.500 (Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number K130199