The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.

(1) IPL Handpiece

Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
Moderate inflammatory acne vulgaris;
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
Cutaneous lesions including scars;
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

(2) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):

Benign vascular and pigmented lesions, age spots:
Nevus spilus:
Tattoo removal.

(3) Long pulsed Nd:YAG Handpiece:

Benign vascular lesions
Superficial and deep telangiectasias (venulectasias)
Benign cutaneous lesions
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 non-ablative treatment of facial wrinkles
Laser skin resurfacing procedures
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation)
Treatment of pseudofolliculitis barbae (PFB)

Device Description

The proposed device, Platform Treatment System, HS-900K can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. These five handpieces are (1) Intense Pulsed Light (IPL) Handpiece, (2) Q-switched Nd:YAG laser Handpiece and (3) Long pulsed Nd:YAG Handpiece. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use.

The main unit consists of:

(1) The Power supply module: Controls electrical supply to the entire system.
(2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
- a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
- b) Emerqency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
- c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system status is displayed on the screen.
(3) The display module: Displays various information of the system and accept users' instruction.
(4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
(5) Cooling system: Maintains a stable thermal environment for optimum performance.
(6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.

AI/ML Overview

The provided text is an FDA 510(k) premarket notification for a "Platform Treatment System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing performed. However, there is no information presented in this document regarding acceptance criteria for clinical performance, or a study proving that the device meets such criteria.

The document explicitly states in Section VIII: "Clinical Testing It is not applicable." This means that the 510(k) submission did not include clinical trial data to demonstrate the device's performance. Instead, the submission relies on substantial equivalence to predicate devices and non-clinical testing (electrical safety and electromagnetic compatibility) to support its clearance.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: No clinical performance acceptance criteria or reported performance is mentioned.
Sample sizes used for the test set and the data provenance: No clinical test set data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
Adjudication method: Not applicable as there's no clinical test set.
MRMC comparative effectiveness study: Not applicable as no clinical study was performed.
Standalone performance (algorithm only without human-in-the-loop performance): This device is a laser/IPL system, not an AI algorithm, and no such study is mentioned.
Type of ground truth used: Not applicable as there's no clinical test set.
Sample size for the training set: Not applicable as there's no AI algorithm with a training set.
How the ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical safety/EMC testing, rather than clinical performance data.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

January 28, 2022

Shanghai Apolo Medical Technology Co., Ltd. Felix Li RA Supervisor Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai, Shanghai 200231 China

Re: K203395

Trade/Device Name: Platform treatment 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: ONF, GEX Dated: October 21, 2021 Received: November 1, 2021

Dear Felix Li:

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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K203395

Device Name Platform Treatment System

Indications for Use (Describe)

(1) IPL Handpiece

Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
Moderate inflammatory acne vulgaris;
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
Cutaneous lesions including scars;
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

(2) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):

Benign vascular and pigmented lesions, age spots:
Nevus spilus:
Tattoo removal.

(3) Long pulsed Nd:YAG Handpiece:

Benign vascular lesions
Superficial and deep telangiectasias (venulectasias)
Benign cutaneous lesions
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 non-ablative treatment of facial wrinkles
Laser skin resurfacing procedures
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation)
Treatment of pseudofolliculitis barbae (PFB)

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.

FORM FDA 3881 (7/17)

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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:

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510(k) summary

l Submitter

Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District, 200231, Shanghai China

Establishment Registration Number: 3007120647

Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn

Date of preparation: Jan 27th, 2022.

II Proposed Device

Trade Name of Device:	Platform Treatment System
Common name:	Powered Laser Surgical Instrument
Regulation Number:	21 CFR 878.4810
Regulatory Class:	Class II
Product code:	GEX
Review Panel	General & Plastic Surgery

III Predicate Devices

510(k) Number:	K200746
Trade name:	IPL Treatment System
Common name:	Low Level Laser System for Aesthetic Use
Classification:	Class II
Product Code:	ONF
Manufacturer	Shanghai Apolo Medical Technology Co., Ltd.

510(k) Number:	K192856
Trade name:	MT One

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Common name:	Powered Laser Surgical Instrument
Classification:	Class II
Product Code:	GEX, ONG, ONF, ONE
Manufacturer	M&T SRL
510(k) Number:	K072564
Trade name:	Harmony XL Multi-Application Platform and Thermoelectric Cooler
Common name:	Powered Laser Surgical Instrument
Classification:	Class II
Product Code:	GEX, FTC, HHR, LNK
Manufacturer	Alma Lasers, Ltd.

IV Device description

The main unit consists of:

(1) The Power supply module: Controls electrical supply to the entire system.
(2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
- a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
- b) Emerqency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
- c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system

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

status is displayed on the screen.

(3) The display module: Displays various information of the system and accept users' instruction.
(4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
(5) Cooling system: Maintains a stable thermal environment for optimum performance.
(6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.

V Indication for use

(1) IPL Handpiece

Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
Moderate inflammatory acne vulgaris;
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
Cutaneous lesions including scars;
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias,

erythema of rosacea, leq veins, spider angiomas and venous malformations.

(2) Q-switched Nd:YAG laser Handpiece (1064nm wavelength):

Benign vascular and pigmented lesions, age spots;
Nevus spilus;
Tattoo removal.

(3) Long pulsed Nd:YAG Handpiece:

Benign vascular lesions
Superficial and deep telangiectasias (venulectasias)
Benign cutaneous lesions
Pigmented lesions to reduce lesion size, for patients with lesions that would

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

potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The non-ablative treatment of facial wrinkles
Laser skin resurfacing procedures
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation)
Treatment of pseudofolliculitis barbae (PFB)

ltem Proposed device Predicate device Discussion (IPL Treatment System K200746) Indication for The Platform Treatment The IPL treatment Identical use System with IPL system is intended for handpiece is intended medical use in the for medical use in the treatment of the treatment of following dermatoloqic the following dermatologic conditions: conditions: - Permanent Permanent hair hair reduction - longreduction - long-term term stable reduction in stable reduction in number of hairs renumber of hairs regrowing after growing after a a treatment regimen; treatment regimen; -Moderate inflammatory Moderate acne vulgaris; - Benign inflammatory acne pigmented epidermal vulgaris; - Benign lesions including pigmented epidermal dyschromia, lesions including hyperpigmentation, dyschromia. melasma. ephelides hyperpigmentation. (freckles); - Cutaneous melasma, ephelides lesions including scars; (freckles): -Benign cutaneous Cutaneous lesions .

VI Comparison of technological characteristics with the predicate devices

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	vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.	including scars; -Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
Light source	Intense pulsed light(Xenon Flash Lamp)	Intense pulsed light(Xenon Flash Lamp)	Identical
Wavelength range	420 – 1200 nm	420 – 1200 nm	Identical
Energy output	4.1-50.8 J/cm²	4.1-50.8 J/cm²	Identical
Pulse width	5-20 ms	5-20 ms	Identical
Pulse duration	5-50 ms	5-50 ms	Identical
Spot size	1235mm, 1550mm	1235mm, 1550mm	Identical
Filters	420 -1200nm: Acne;510 -1200nm: Acne,vascular, pigment;560 -1200nm: Acne,vascular, pigment;610-1200nm: Hair removal;640-1200nm: Hair removal;690-1200nm: Hair removal;	420 -1200nm: Acne;510 -1200nm: Acne,vascular, pigment;560 -1200nm: Acne,vascular, pigment;610-1200nm: Hair removal;640-1200nm: Hair removal;690-1200nm: Hair removal;	Identical
Fluences	420 -1200nm: 4.1-50.8J/ cm²;510 -1200nm: 3.8-47 J/cm²;560 -1200nm: 3.7-43.3 J/ cm²;	420 -1200nm: 4.1-50.8J/ cm²;510 -1200nm: 3.8-47 J/cm²;560 -1200nm: 3.7-43.3 J/ cm²;	Identical
	610-1200nm: 3.5-38.7 J/ cm²;640-1200nm: 3.3-37.4J/cm²;690-1200nm: 3.1-33.4J/cm²;	610-1200nm: 3.5-38.7 J/ cm²;640-1200nm: 3.3-37.4J/ cm²;690-1200nm: 3.1-33.4J/ cm²;
Outputmode	Pulse mode	Pulse mode	Identical
Delivermaterials	Direct sapphireCoupling	Direct sapphireCoupling	Identical

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Item	Proposed device	Predicate device(MT ONE K192856)	Discussion
Indication foruse	The Platform TreatmentSystem with 532/1064nm Nd:YAG Q-SwitchLaser Handpiece isindicated for:• Benign vascular andpigmented lesions, agespots;• Nevus spilus;• Tattoo removal.	The MT ONE with532/1064 nm Nd:YAGQ-Switch LaserHandpiece is indicatedfor:• Benign vascular andpigmented lesions,age spots;• Nevus spilus;• Tattoo removal.	Identical
Wavelengthrange	532/1064 nm	532/1064 nm	Identical
Energyoutput	Max 1.2J (532nm)Max 2.4J (1064nm)	3.2 J/cm² (532nm)Φ8mm4 J/cm² (1064nm)Φ8mm	Equivalent
Spot size	1,2,3,4,5 mm	1,2,3,4,5,8 mm	Equivalent
Frequency	1 to 10 Hz	Up to 10 Hz	Identical
Pulseduration	< 10 ns	15 ns
Delivermaterials	Direct sapphireCoupling	Direct sapphireCoupling	Identical

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Item	Proposed device	Predicate deviceHarmony XL Multi-application PlatformK072564	Discussion
Indication for use	The Platform Treatment System with 1064 nm Long Pulse Nd:YAG Laser Handpiece is indicated for:• Benign vascular lesions• Superficial and deep telangiectasias (venulectasias)• Benign cutaneous lesions• 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 non-ablative treatment of facial wrinkles• Laser skin resurfacing procedures• Reduction of red pigmentation in hypertrophic and	The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of.• Benign vascular lesions such as, but not limited to treatment of:> Port wine stains> Hemangiomas> Warts• Superficial and deep telangiectasias (venulectasias)> Reticular veins (0.1-4.0 mm dia.) of the leg> Rosacea> Venus lake> Leg veins> Spider veins> Poikiloderma of Civatte> Angiomas• Benign cutaneous lesions, such as, but not limited to:> Warts> Scars	Identical

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keloid scars wherevascularity is anintegral part of thescar. Indicated for use onall skin types(Fitzpatrick I-VI),including tannedskin. Removal ofunwanted hair, forstable long-term, orpermanent, hairreduction throughselective targetingof melanin in hairfollicles. Removal orlightening ofunwanted hair (withand withoutadjuvantpreparation) Treatment ofpseudofolliculitisbarbae (PFB)	Striae Psoriasis Solar lentigos (sunspots) Cafd-au-laitmacules Seborrheickeratoses Nevi and nevus ofOta Chloasma Verrucae Skin tags Keratoses The removal ofblack, blue orgreen tattoos(significantreduction in theintensity of blackand /or blue/blacktattoos). Plaques Pigmented lesions toreduce lesion size, forpatients with lesionsthat would potentiallybenefit fromaggressive treatment,and for patients withlesions that have notresponded to otherlaser treatments. The non-ablativetreatment of facialwrinkles, such as, butnot limited to: Periocularwrinkles Perioral wrinkles		Laser skinresurfacingprocedures for thetreatment of: Acne scars Wrinkles Reduction of redpigmentation inhypertrophic andkeloid scars wherevascularity is anintegral part of thescar. Indicated for use onall skin types(Fitzpatrick I-VI),including tanned skin. The 1064 nm Nd:YAGlasers (Long Pulsedonly, with and withoutcontact-cooling) isindicated for: Removal ofunwanted hair, forstable long-term, orpermanent, hairreduction throughselective targeting ofmelanin in hairfollicles. Removal orlightening of unwantedhair (with and withoutadjuvant preparation) Treatment ofpseudofolliculitisbarbae (PFB)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Wavelength range	1064 nm	1064 nm	Identical
Fluence	10 ~ 500 J/ cm²	Up to 30 ~ 450J/ cm²	Equivalent
Spot size	2.2x5mm, ¢6mm, ¢ 9mm	2,6,10mm	Equivalent
Frequency	1 Hz	1 Hz	Equivalent
Pulse duration	10 ~ 40ms	10, 12, 15, 45ms	Equivalent
Deliver materials	Aluminum alloy	Aluminum alloy	Identical

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VII Non-Clinical Testing

A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

Electrical safety and electromagnetic compatibility

60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical ● IEC electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and ● requirements
IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-57: 2011 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

VIII Clinical Testing

lt is not applicable.

ed on the perormance testing and validation studies that the subject device is substantially equivalent to the predicate device.

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.