Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

port wine birthmarks
telangiectasias
spider angioma
Cherry angioma
Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

cafe-au-Iait birthmarks
Ephalides, solar lentigines
senile lentigines
Becker's nevi
freckles
common nevi
nevus spilus
Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

nevus of Ota
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 the treatment of acne scars and wrinkles

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for benign pigmented lesion size, for patients with benign lesions that would potentiallybenefit from aggressive treatment, and for patients with benign that have not responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

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

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Device Description

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser).

Chrome, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

It can also be connected to Er:YAG handpieces cleared under K173002.

Chrome, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed or variable handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

Chrome is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not contain information about acceptance criteria for performance, device performance metrics, or any clinical study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, or training set details).

The document focuses on regulatory approval (510(k) premarket notification) for a laser device called "Chrome." It establishes "substantial equivalence" to predicate devices, primarily based on technological characteristics and safety standards.

The sections that might typically contain such information (like "Performance data" and "Technological Characteristics Comparison") focus on:

Performance data: Lists recognized consensus safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and states that "Software Verification and Validation Testing" was conducted. It also mentions biocompatibility was established by comparison to a predicate. This refers to safety and electrical performance standards, not clinical efficacy or diagnostic accuracy.
Technological Characteristics Comparison: Compares specific technical parameters (laser wavelengths, pulse width, max fluence, spot size, repetition rate, microbeam handpiece details, IPL wavelengths) of the Chrome device to two predicate devices. This demonstrates that the device operates within similar technical specifications as already approved devices, not that it has met specific clinical performance criteria.

Therefore, I cannot populate the requested table and answer the detailed questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided document.

The document primarily demonstrates:

Indications for Use: What conditions the device is intended to treat (various dermatological conditions, tattoo removal, hair reduction, etc.).
Technological Equivalence: That its technical specifications (laser types, wavelengths, power, etc.) are comparable to previously cleared devices.
Safety & Standards Compliance: That it complies with general safety and electrical standards for medical devices and lasers.

This type of 510(k) submission often does not require new clinical studies if substantial equivalence can be established based on technological characteristics and intended use compared to legally marketed predicate devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 18, 2020

Quanta System Spa Francesco Dell'Antonio Vice President Regulatory Affairs and QA via Acquedotto, 109 Samarate (Va), 21017 Italy

Re: K202503

Trade/Device Name: Chrome 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: August 20, 2020 Received: August 31, 2020

Dear Francesco Dell'Antonio:

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 and Part 809); 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 (OS) 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 medical devices and radiation-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 Acting 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

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Indications for Use

510(k) Number (if known) K202503

Device Name Chrome

Indications for Use (Describe)

General intended use

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

port wine birthmarks
telangiectasias
spider angioma
Cherry angioma
Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

cafe-au-Iait birthmarks
Ephalides, solar lentigines
senile lentigines
Becker's nevi
freckles
common nevi
nevus spilus
Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

nevus of Ota
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 the treatment of acne scars and wrinkles

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

1064 nm (pulsed)

Dermatology/Plastic Surgery:

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

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

IPL 550-1200nm; 570-1200nm

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

K202503

5. 510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPAEmail: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	10th November 2020
Device Name:	Chrome
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Main Predicate Device	Pico Platform (K191842), Quanta System SpA
Reference Device	Evo family (K160368), Quanta System SpA

Performance Standards:

There are no mandatory performance standards for this device.

Description of the device:

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser).

It can also be connected to Er:YAG handpieces cleared under K173002.

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Chrome, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

Chrome is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

Indication for use General intended use

Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to:

। port wine birthmarks
telangiectasias
י spider angioma
-Cherry angioma
-Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

cafe-au-lait birthmarks
-Ephalides, solar lentigines
senile lentigines
-Becker's nevi
freckles
common nevi
nevus spilus
-Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

5-2

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

Removal of dark ink (black, blue and brown) tattoos Removal of benign pigmented lesions including;

। nevus of Ota
-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 the treatment of acne scars and wrinkles

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of 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, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The laser is also indicated for the treatment of facial wrinkles.

lt is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for benign pigmented lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.

lt is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

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

IPL 550-1200nm; 570-1200nm

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

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

Technological Characteristics Comparison

Specification	Main predicate device	Additional reference device	Subject device
Device Name(K number)	Pico Family K191842	EVO Platform K160368	Chrome
Submitter	Quanta System SpA	Quanta System SpA	Quanta System SpA
Product Code	GEX	GEX	GEX
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Class	II	II	II
Laser Sources	Nd:YAG, and Ruby	Nd:YAG, Ruby and Alexandrite	Nd:YAG
LaserWavelengths[nm]	☑ 1064nm Q-Switched(Nanosecond mode)☑ 1064nm (picosecond mode)☐ 1064nm non-Q-Switched(pulsed mode)☑ 532 nm Q-Switched(Nanosecond mode)☑ 532 nm (picosecond mode)☑ 694nm Q-Switched(Nanosecond mode)☑ 694nm non-Q-Switched (freerunning mode)	☑ 1064nm Q-Switched(Nanosecond mode)☑ 1064nm non-Q-Switched(pulsed mode)☑ 532 nm Q-Switched(Nanosecond mode)☑ 532nm pulsed☑ 1320nm pulsed☑ 755nm pulsed☑ 694nm Q-Switched(Nanosecond mode)☑ 694nm non-Q-Switched (freerunning mode)	☑ 1064nm Q-Switched(Nanosecond mode)☑ 1064nm non-Q-Switched(pulsed mode)☑ 532 nm Q-Switched(Nanosecond mode)☐ 532nm pulsed☐ 1320nm pulsed☐ 755nm pulsed☑ 694nm Q-Switched(Nanosecond mode)☑ 694nm non-Q-Switched (freerunning mode)☐ 532 nm (picosecond mode)☐ 1064nm (picosecond mode)
IPLwavelengths[nm]	650-1200nm625-1200nm590-1200nm570-1200nm550-1200nm400-1200nm	650-1200nm625-1200nm590-1200nm570-1200nm550-1200nm400-1200nm	650-1200nm625-1200nm590-1200nm570-1200nm550-1200nm400-1200nm
1064nm (Q-Switched, nanosecond mode)
Homogeneous spot
Pulse width	6 to 12 ns	6 to 12 ns	6 to 12 ns
Max Fluence	Up to 38J/cm²	Up to 50J/cm²	Up to 48J/cm²
Spot Size	2 to 12 mm diameter Round;2x2, 3x3, 4x4, 5x5, 7x7 mm²Squared	2 to 12 mm diameter Round;2x2, 3x3, 4x4, 5x5, 9x9 mm²Squared	2 to 8 mm diameter Round;2x2, 3x3, 4x4, 5x5, 7x7 mm²Squared
Specification	Main predicate device	Additional reference device	Subject device
Device Name(K number)	Pico Family K191842	EVO Platform K160368	Chrome
Submitter	Quanta System SpA	Quanta System SpA	Quanta System SpA
RepetitionRate	Up to 10 Hz	Up to 10 Hz	Up to 20 Hz
HighcoveragemicrobeamHandpiece	Present	Absent	Present
MicrobeamhandpieceFluence perdot	6 J/cm²	N/A	From 0.2 to 16.5 J/cm²
Microbeamhandpiecespotdimension(mm)	9 mm diameter	N/A	9 mm diameter
StandardmicrobeamHandpiece	Present	Absent	Present
MicrobeamhandpieceFluence perdot	Up to 38J/cm²	N/A	From 0.03 to 44.4 J/cm2
Microbeamhandpiecespotdimension(mm)	8 mm diameter	N/A	8 mm diameter
	1064 nm (non Q-Switched - pulsed mode)
Pulse width	N/A	0.25 to 300 ms	0.3 to 50 ms
Max Fluence	N/A	300 J/cm²	300 J/cm²
Spot Size	N/A	2 to 24 mm diameter Round;2x2, 3x3, 4x4, 5x5, 9x9 mm²Squared	2 to 8 mm diameter Round;2x2, 3x3, 4x4, 5x5, 7x7 mm2Squared
RepetitionRate	N/A	Up to 10 Hz	Up to 10 Hz
	532nm (Q-Switched, nanosecond mode)
Homogeneous spot
Pulse width	6 to 12 ns	6 to 12 ns	6 to 12 ns
Max Fluence	Up to 14 J/cm²	Up to 19 J/cm²	Up to 15 J/cm²
Spot Size	2 to 12 mm diameter Round;2x2, 3x3, 4x4, 5x5, 7x7 mm²Squared	2, 4, 6, 8 mm diameter Round;2x2, 3x3, 4x4, 5x5 mm² Squared	3 to 10.5 mm diameter Round;2x2, 3x3, 4x4, 5x5, 7x7 mm2Squared
RepetitionRate	Up to 10 Hz	Up to 10 Hz	Up to 20 Hz
HighcoveragemicrobeamHandpiece	Present	Absent	Present
MicrobeamhandpieceFluence perdot	3.5 J/cm²	N/A	from 0.05 to 5.95 J/cm2
Specification	Main predicate device	Additional reference device	Subject device
Device Name(K number)	Pico Family K191842	EVO Platform K160368	Chrome
Submitter	Quanta System SpA	Quanta System SpA	Quanta System SpA
Microbeamhandpiecespotdimension(mm)	9 mm diameter	N/A	9 mm diameter
StandardmicrobeamHandpiece	Present	Absent	Present
MicrobeamhandpieceFluence perdot	Up to 14 J/cm²	N/A	From 0.3 to 14.9 J/cm2
Microbeamhandpiecespotdimension(mm)	8 mm diameter	N/A	8 mm diameter
IPL 650-1200 nm, 625-1200 nm, 590-1200 nm, 570-1200 nm, 550-1200 nm, 400-1200 nm
Pulse width	Up to 40ms	Up to 40ms	Up to 40ms
Max Fluence	up to 25 J/cm²	up to 25 J/cm²	up to 25 J/cm²
Spot Size	48mm x13 mm25mm x13 mm	48mm x13 mm25mm x13 mm	48mm x13 mm25mm x13 mm
	RepetitionRate	up to 0,5 Hz	up to 0,5 Hz

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

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

Performance data:

The subject device was subjected to performance testing in accordance with the following recognized consensus standards:

IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment Part 1: General Requirements For Basic i Safety And Essential Performance
i 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
। IEC 60825-1 Ed. 3.0 (2014) Safety of laser products – Part 1: Equipment classification and requirements

The following testing were performed on the subject device:

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

-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".

Biocompatibility:

Biocompatibility of the subject device was established based on a comparison to the legally-marketed predicate device, as the patient-contacting components of the subject device in its final finished form are identical to that of K191842 in formulation, processing, sterilization, and geometry, and no other chemicals have been added.

Conclusions:

The subject device has the same intended use, the same indications for use and the same fundamental scientific technology as its predicates.

The performance specification of the subject device are equivalent to its identified predicate devices and therefore do not present any new concerns of safety and effectiveness.

Therefore, Chrome 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.