Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the laser technology, cooling system, and user interface for parameter selection. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, decision-making, or automated control beyond basic system functions.

Therapeutic

Yes
The device is indicated for the treatment of numerous medical conditions, including vascular lesions, pigmented lesions, and wrinkles, which constitutes therapeutic use.

Diagnostic

No

Explanation: The device is indicated for therapeutic purposes like hair reduction, treatment of pigmented and vascular lesions, and wrinkle treatment, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as laser resonators, optical fibers, handpieces, and a control panel with an LCD touch screen, indicating it is a physical laser system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided text, the CLARITY LPC Laser System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended uses listed are all related to treating conditions on the human body (hair reduction, pigmented lesions, wrinkles, vascular lesions). IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The device description details a laser system that delivers energy to the skin via a handpiece. This is consistent with a therapeutic or aesthetic device, not a device that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with IVD devices.

Therefore, the CLARITY LPC Laser System is a medical device, but it falls under a different classification than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

None presented.

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

Not Found

Predicate Device(s): 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.

K112715

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

Regulation Number and Section

§ 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.

Summary

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