The HOLLYWOOD SPECTRA System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

Tattoo removal: dark ink (black, blue, and brown)
Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of melasma

1064nm in Spectra (long-pulse) mode:

Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris

532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces):

Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of Lentigines
Treatment of Café-au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyperpigmentation
Treatment of Becker's Nevi, Freckles, and Nevi spilus

Device Description

The HOLLYWOOD SPECTRA Laser System contains a Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates Q-switched and/or pulsed laser sources at the nominal wavelength of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (655 nm) are delivered by articulated arm to a fixed (collimated), or focusing variable (zoom) spot handpiece, or a dual focused dots microbeam handpiece, or a 585nm/650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or 650 nm wavelengths, correspondingly.

When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromophores such as melanin and tattoo particles. This increases localized temperature of the chromophores. The instantaneous temperature-increase causes fragmentation of the chromophores to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size. The HOLLYWOOD SPECTRA laser system is controlled via a touchscreen guided user interface in the front of the device.

AI/ML Overview

The provided text is a 510(k) summary for the HOLLYWOOD SPECTRA Laser System. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and indications for use, rather than presenting performance data from clinical studies directly.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance data from a study that proves the device meets those criteria.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The tables provided (Table 1 and Table 2) are "Technical Characteristics Comparison" tables, comparing the proposed device's specifications to those of predicate devices. These are not acceptance criteria tables from a performance study.
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "PERFORMANCE DATA" section (Page 13) of the summary lists various types of engineering and safety testing performed (Biocompatibility, Sterilization and Shelf-Life, Electrical Safety and EMC, Software Verification and Validation, Performance Bench Testing). However, these are bench tests and safety compliance tests, not clinical performance studies with acceptance criteria for specific medical outcomes or diagnostic accuracy. The purpose of these tests is to show that the device is safe and functions according to its design specifications, and is substantially equivalent to existing devices, not to demonstrate clinical efficacy against pre-defined acceptance criteria in a patient population.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 4, 2022

Lutronic Corporation Haewon Park Regulatory Affairs Specialist Lutronic Center, 219, Sowon-Ro Deogyang-gu, Goyang-Si, Geonggi-do 410220 Korea, South

Re: K213569

Trade/Device Name: HOLLYWOOD SPECTRA 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 29, 2021 Received: November 9, 2021

Dear Haewon Park:

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}------------------------------------------------

Indications for Use

510(k) Number (if known) K213569

Device Name HOLLYWOOD SPECTRA Laser System

Indications for Use (Describe)

1064nm in nanosecond mode, including microbeam handpieces:

Tattoo removal: dark ink (black, blue, and brown)
Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of melasma

1064nm in Spectra (long-pulse) mode:

Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris

532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces):

Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of Lentigines
Treatment of Café-au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyperpigmentation
Treatment of Becker's Nevi, Freckles, and Nevi spilus

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

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."

{4}------------------------------------------------

510(k) SUMMARY (K213569)

Lutronic Corporation HOLLYWOOD SPECTRA Laser System

I. SUBMITTER

Lutronic Corporation Lutronic Center 219, Sowon-Ro Deogyang-Gu, Goyang-Si, Gyeonggi-do, 10534 Republic of Korea

Contact Person

Haewon Park, PhD 19 Fortune Dr. Billerica, MA 01821 Phone: 1-978-447-4763

Date Revised: January 31st, 2022

II. DEVICE

Trade Name:	HOLLYWOOD SPECTRA Laser System
Common or Usual Name:	Surgical Laser
Classification Name:	GEX – Powered Laser Surgical Instrument For Use in General andPlastic Surgery and Dermatology21 C.F.R. 878.4810, Class II

III. PREDICATE DEVICES

1. Primary Predicate Device
Trade Name:	SPECTRA Laser System
Common or Usual Name:	Surgical Laser
Classification Name:	GEX – Powered Laser Surgical Instrument for use in General andPlastic Surgery and Dermatology21 C.F.R. 878.4810, Class II
Premarket Notification:	Lutronic Corporation K113588 (2/2/2012)
2. Secondary Predicate Device
Trade Name:	Chrome
Common or Usual Name:	Surgical Laser
Classification Name:	GEX - Powered Laser Surgical Instrument for use in General andPlastic Surgery and Dermatology21 C.F.R. 878.4810, Class II
Premarket Notification:	Quanta System SPA K202503 (11/18/2020)

{5}------------------------------------------------

3. Tertiary Predicate Device
Trade Name:	Fotona QX Nd:YAG/KTP Laser System Family
Common or Usual Name:	Nd:YAG/KTP Dermatology and Surgical Laser
Classification Name:	GEX – Powered Laser Surgical Instrument for use in General and
	Plastic Surgery and Dermatology
	21 C.F.R. 878.4810, Class II
Premarket Notification:	Fotona d.o.o K083889 (4/23/2009)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The HOLLYWOOD SPECTRA Laser System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

Tattoo removal: dark ink (black, blue, and brown) -

{6}------------------------------------------------

-Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation -
-Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles -
Treatment of melasma -

1064nm in Spectra (long-pulse) mode:

Treatment of wrinkles -
Treatment of mild to moderate inflammatory acne vulgaris -

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):

Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) -
Removal of Epidermal Pigmented Lesions -
Removal of Minor Vascular Lesions including but not limited to telangiectasias -
Skin resurfacing procedures for the treatment of acne scars and wrinkles -
Treatment of Lentigines -
Treatment of Café-au-Lait -
Treatment of Seborrheic Keratoses -
Treatment of Post Inflammatory Hyperpigmentation -
Treatment of Becker's Nevi, Freckles, and Nevi spilus -

{7}------------------------------------------------

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Lutronic Corporation believes that the HOLLYWOOD SPECTRA Laser System described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to three legally marketed predicate devices that are Class II medical device. As shown in the Technical Characteristics Comparison (Table 1), the 1064 nm and 532 nm functions of the HOLLYWOOD SPECTRA Laser System are substantially equivalent to the 1064 nm and 532 nm functions of the Lutronic Corporation SPECTRA Laser System, Quanta Chrome, and Fotona QX Nd:YAG/KTP Laser System Family. As shown in Table 2, the microbeam handpiece's technological and performance characteristics of the HOLLYWOOD SPECTRA Laser System are substantially equivalent to those of the Quanta Chrome's standard microbeam handpiece.

Utilizing FDA's Guidance for Industry and FDA Staff "Format for traditional and Abbreviated 510(k)s", the proposed device, the HOLLYWOOD SPECTRA Laser System is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The HOLLYWOOD SPECTRA Laser System is as safe, as effective, and performs as well as the predicate devices.

{8}------------------------------------------------

Table 1. Technical Characteristics Comparison

	This SubmissionHOLLYWOODSPECTRA	Predicate 1SPECTRA	Predicate 2Chrome	Predicate 3Fotona QX
510(k)	K213569	K113588	K202503	K083889
Applicant	Lutronic	Lutronic	Quanta	Fotona d.o.o
Product CodeClassificationRegulation Num	GEXClass II21 CFR 878.4810	GEXClass II21 CFR 878.4810	GEXClass II21 CFR 878.4810	GEXClass II21 CFR 878.4810
Laser SourceWavelength	Nd:YAG1064nm, 532nm	Nd:YAG1064nm, 532nm	Nd:YAG1064nm, 532nm	Nd:YAG1064nm, 532nm
Modes	QS ModeQ-PTP, Q-3, Q-4 ModeSpectra Mode (Long-pulseMode)532 Mode	QS ModeSpectra Mode (Long-pulse Mode)532 Mode	QS ModeIPLPulsed Mode	QS ModeLong-Pulse Mode
Pulse Duration	1064 nm5-10 ns (QS, Q-PTP mode)10-20 ns (Q-3, Q-4 mode)0.3 ms (Long-pulse)	1064 nm5-10 ns (QS)0.3 ms (Long-pulse)	1064 nm6 -12 ns (QS)0.3-50 ms (Pulsed mode)	1064 nm5-20 ns (QS)0.25 ms (Long pulse)
	532 nm5-10 ns (Q-switched)	532 nm5-20 ns (Q-switched)	532 nm6 -12 ns (Q-switched)IPLUp to 40 ms (IPL)	532 nm5-20 ns (Q-switched)
Max Energy	1064 nmUp to 1200 mJ (Q-switched)Up to 1500 mJ (Spectra)Up to 1400 mJ (Q-PTP, Q-3,Q-4)	1064 nmUp to 1200 mJ (Q-switched)Up to 1500 mJ (Spectra)	1064nmUp to 1600 mJ (Q-switched)Up to 15000 mJ (longpulsed)	1064 nmUp to 1600 mJ (Q-switched)Up to 5000 mJ (longpulsed)
	532 nmUp to 400 mJ (Q-switched)	532 nmUp to 600 mJ (Q-switched)	532nmUp to 800 mJ (Q-switched)	532 nmUp to 600 mJ (Q-switched)
			IPLNA
Max. Fluence	1064 nmUp to 12 J/cm²	1064 nmUp to 12 J/cm²	1064 nmUp to 48 J/cm² (Q-switched)Up to 300 J/cm² (pulsedmode)	1064 nmUp to 12.7 J/cm²
	532 nmUp to 6.3 J/cm²	532 nmUp to 6.3 J/cm²	532 nmUp to 15 J/cm² (Q-switched)
Spot Size	1064 nm	1064 nm	1064 nm	1064, 532 nm
	Zoom handpiece1 to 7 mm (Q-Switch, Spectra)2 to 7 mm (Q-PTP, Q-3, Q-4)8mm-Zoom-Collimated3, 4, 5, 6, 7, 8 mm	Zoom handpiece1 to 7 mm (Q-Switch, Spectra)8mm-Zoom-Collimated3, 4, 5, 6, 7, 8 mm	2 to 8 mm diameter2x2, 3x3, 4x4, 5x5, 7x7 mm²532 nm3 to 10.5 mm diameter	2 to 8 mm diameter
	532 nmZoom handpiece0.8 to 6.0 mm diameter8mm-Zoom-Collimated2.6, 3.4, 4.3, 5.2, 6.0, 6.9 mm	532 nmZoom handpiece0.8 to 6.0 mm diameter8mm-Zoom-Collimated2.6, 3.4, 4.3, 5.2, 6.0, 6.9 mm
Repetition Rate	1064, 532 nmUp to 10 Hz585nm S1, 1, 2, 5 Hz650nm S1, 1, 2 Hz	1064, 532 nmUp to 10 Hz	1064, 532 nmUp to 20 Hz	1064, 532 nmUp to 10 Hz
Delivery	Articulated arm	Articulated arm	Articulated arm	Articulated arm

{9}------------------------------------------------

Table 2. Technological Characteristics Comparison for the Microbeam Handpiece

	This SubmissionHOLLYWOODSPECTRA	Predicate 1SPECTRA	Predicate 2Chrome	Predicate 3Fotona QX
510(k)	K213569	K113588	K202503	K083889
Applicant	Lutronic	Lutronic	Quanta	Fotona d.o.o
MicrobeamHandpiece	Present	Absent	Present	Absent
MicrobeamHandpieceFluence per dot	1064 nm1.09~~40.63 J/cm²532 nm0.16~~16.40 J/cm²	NA	1064nm0.03~~44.4 J/cm² (Standard)0.2~~16.5 J/cm² (High Coverage)532 nm0.3~~14.9 J/cm² (Standard)0.05~~5.95 J/cm² (HighCoverage)	NA
MicrobeamHandpieceSpot Size	1064 nm8mm532 nm6.9mm	NA	1064, 532 nm8 mm (Standard)9 mm (High Coverage)	NA
MicrobeamHandpiecePeak Power perdot**	0.28 GW (1064 nm)0.08 GW (532 nm)	NA	0.3 GW (1064 nm)0.083 GW (532 nm)	NA
	This SubmissionHOLLYWOOD SPECTRAK213569	Predicate 1SPECTRAK113588	Predicate 2ChromeK202503	Predicate 3Fotona QXK083889
510(k)
Applicant	Lutronic	Lutronic	Quanta	Fotona d.o.o
Indication ForUse	The Hollywood Spectra System isintended for use in aesthetic, cosmeticand surgical applications requiringincision, excision, ablation,vaporization of soft tissues for generaldermatology, dermatologic and generalsurgical procedures for coagulationand hemostasis.	The SPECTRA Laser System isindicated for the incision, excision,ablation, vaporization of soft tissuesfor general dermatology, dermatologicand general surgical procedures forcoagulation and hemostasis.	Quanta Chrome (K202503) is cleared forthe treatment of benign vascular lesions,benign pigmented lesions, and for hair,tattoo removal and the incision, excision,ablation, vaporization of soft tissue forGeneral dermatology such as, but notlimited to treatment of:	1064 nm wavelength in Q-switched mode:- Removal of dark ink (black,blue, and brown) tattoos- Treatment of nevus of Ota- Treatment of common nevi- Removal or lightening ofunwanted hair- Skin resurfacing proceduresfor the treatment of acne scarsand wrinkles
	1064nm in nanosecond mode,including microbeam handpieces:-Tattoo removal: dark ink (black, blue,and brown)-Removal of Nevus of Ota-Removal or lightening of unwantedhair with or without adjuvantpreparation-Treatment of Common Nevi-Skin resurfacing procedures for thetreatment of acne scars and wrinkles-Treatment of melasma	532nm Wavelength (nominaldelivered energy of 585 nm and 650nm with optional dye handpieces):- Tattoo removal: light ink (red, tan,purple, orange, sky blue, green)- Removal of Epidermal PigmentedLesions- Removal of Minor Vascular Lesionsincluding but not limited totelangiectasias- Treatment of lentigines- Treatment of Café-au-Lait- Treatment of Seborrheic Keratoses- Treatment of Post InflammatoryHyperpigmentation- Treatment of Becker's Nevi,Freckles, and Nevi Spilus	532 nm (Q-Switched, nanosecond mode),including microbeam handpieces:Removal of light ink (red, sky blue, green,tan, purple, and orange) tattoosTreatment of benign vascular lesionsincluding, but not limited to:- port wine birthmarks- telangiectasias- spider angioma- Cherry angioma- Spider neviTreatment of benign pigmented lesionsincluding, but not limited to:- cafe-au-lait birthmarks- Ephalides, solar lentigines- senile lentigines- Becker's nevi- freckles- common nevi- nevus spilus- Ota NevusTreatment of seborrheic keratosisTreatment of post inflammatoryhyperpigmentationSkin resurfacing procedures for thetreatment of acne scars and wrinkles.
	1064nm in Spectra (long-pulse)mode:-Treatment of wrinkles-Treatment of mild to moderateinflammatory acne vulgaris	1064 nm Wavelength:- Tattoo removal: dark ink (black, blueand brown)- Removal of Nevus of Ota- Removal or lightening of unwantedhair with or without adjuvantpreparation- Treatment of Common Nevi- Skin resurfacing procedures for thetreatment of acne scars and wrinkles- Treatment of melasma	1064 nm (Q-Switched, nanosecondmode), including microbeam handpieces:Removal of dark ink (black, blue andbrown) tattoosRemoval of benign pigmented lesionsincluding	1064 nm wavelength in non-Q-switched mode:- Removal of unwanted hair,for stable long term orpermanent hair reduction andfor treatment of PFB. Thelaser is indicated for all skintypes, Fitzpatrick I-VI,including tanned skin- Photocoagulation andhemostasis of pigmented andvascular lesions, such as, butnot limited to,- port wine stains,hemangioma, warts,telangiectasia, rosacea, venuslake, leg veins and spiderveins- Coagulation and hemostasisof soft tissue- Treatment of wrinkles- Treatment of mild tomoderate inflammatory acnevulgaris
	532nm in nanosecond mode,including microbeam handpieces(nominal delivered energy of 585 nmand 650 nm with optional dyehandpieces):- Tattoo removal: light ink (red, tan,purple, orange, sky blue, green)- Removal of Epidermal PigmentedLesions

** Mathematically derived values

{10}------------------------------------------------

Table3. Indications for Use Statement Comparison

{11}------------------------------------------------

- Removal of Minor Vascular Lesionsincluding but not limited totelangiectasias- Skin resurfacing procedures for thetreatment of acne scars and wrinkles- Treatment of Lentigines- Treatment of Café-au-Lait- Treatment of Seborrheic Keratoses- Treatment of Post InflammatoryHyperpigmentation- Treatment of Becker's Nevi,Freckles, and Nevi spilus	- Café au lait spot- Ephalides, solar lentigo (lentigines)- Becker Nevus- Nevus spilus- Treatment of common nevi- Removal or lightening of unwanted hair- Skin resurfacing procedures for thetreatment of acne scars and wrinkles1064 nm (pulsed) Dermatology/PlasticSurgery:Intended for the coagulation and hemostasisof benign vascular lesions such as, but notlimited to, port wine stains, hemangiomas,warts, telangectasia, rosacea, venus lake,leg veins, spider veins and poikiloderma ofcivatte; and treatment of benign cutaneouslesions such as warts, scars, striae andpsoriasis. The laser is also intended for thetreatment of benign pigmented lesions suchas, but not limited to, lentigos (age spots),solar lentigos (sun spots), cafe au laitmacules, seborrheic keratoses, nevi,chloasma, verrucae, skin tags, keratosis andplaques. The laser is also indicated for thetreatment of wrinkles such as, but notlimited to, periocular and perioral wrinkles.The laser is also indicated for the treatmentof facial wrinkles. Additionally, the laser isindicated for the treatment ofpseudofolliculitis barbae (PFB) and forstable long-term, or permanent hairreduction. Permanent hair reduction isdefined as long-term stable reduction in thenumber of hairs regrowing when measuredat 6, 9 and 12 months after the completionof a treatment regime. It is indicated for thereduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of the scar.The laser is also indicated for benignpigmented lesions to reduce lesion size, forpatients with benign lesions that wouldpotentiallybenefit from aggressivetreatment, and for patients with benignlesions that have not responded to otherlaser treatments. It is indicated for use on allskin types (Fitzpatrick I-VI) includingtanned skin, and the removal and permanent	532 un wavelength in Q-switched mode (nominaldelivered energy of 585 nmand 650 nm with theoptional 585 nm and 650 nmdye converter handpieces):- Removal of light ink (red,sky blue, green, tan, purple,and orange) tattoos- Treatment of vascularlesions including, but notlimited to:- port wine birthmarks- telangiectasias- spider angioma- cherry angioma- spider nevi		reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.IPL 590-1200nm; 625-1200nm; 650-1200nmIndicated for permanent hair removal.Permanent hair reduction is defined as thelong-term, stable reduction in the number ofhairs regrowing when measured at 6, 9, and12 months after the completion of atreatment regimeIPL 550-1200nm; 570-1200nmIndicated for photocoagulation ofdermatological benign vascular lesion (i.e.face telangiectasia), photothermolysis ofblood vessels (treatment of facial and legveins), and treatment of benign pigmentedlesions.IPL 400-1200nm Indicated forinflammatory acne (mild to moderate acnevulgaris).Integrated Skin CoolerThe intended use of the integrated coolingsystem in the laser hand piece is to providecooling of the skin prior to laser treatment,for the reduction of pain during lasertreatment, to allow for the use of higherfluencies for laser treatments such as hairremoval and benign vascular lesion, and toreduce the potential side effects of lasertreatments.
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--

{12}------------------------------------------------

{13}------------------------------------------------

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The tip of handpiece is considered tissue-contacting component for a duration of less than 24 hours and its chemical formulation is Aluminum (Max. 96%, CAS No. 7429-90-S). The contact type of the HOLLYWOOD SPECTRA Laser System is as follows: surface device, intact skin, limited duration.

The biocompatibility evaluation for the HOLLYWOOD SPECTRA Laser System was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," ISO 10993-5, "Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity," and ISO 10993-10, "Biological Evaluation of Medical Devices -Part 10: Tests for irritation and skin sensitization' as recognized by FDA. The handpiece tip testing included the following tests:

. Cytotoxicity
. Dermal Sensitization
Intracutaneous Irritation

Sterilization and Shelf-Life

The HOLLYWOOD SPECTRA Laser System is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with isopropyl alcohol or ethanol of 90% strength or higher. The HOLLYWOOD SPECTRA Laser System is reusable and does not have a restricted shelf-life. The expected service life is about 5 years.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the HOLLYWOOD SPECTRA Laser System, consisting of the system main body, articulated arm, handpieces, and footswitch. The system complies with the following standards for safety and EMC.

IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
IEC 60601-2-22: 2012-10 ed 3.1, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment

{14}------------------------------------------------

IEC 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.

Performance Bench Testing

Test was performed to ensure that the HOLL YWOOD SPECTRA Laser System performs as intended and documentation was provided. Testing included laser pulse width, laser pulse repetition rate, laser pulse energy, laser beam spectrum and bandwidth, laser beam spot size, and flash lamp lifetime.

VIII. CONCLUSIONS

The HOLLYWOOD SPECTRA Laser System has the same intended use, similar indications for use, and the same fundamental scientific technology as its predicates. The technology and performance specifications of the subject device are equivalent to its identified predicate devices and therefore do not present any new concerns of safety and effectiveness. Therefore, the HOLLYWOOD SPECTRA Laser System is as safe, as effective, and performs as well as the legally marketed predicate devices.

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.