PHOTODERM PL.

K960772 · Esc Medical Systems , Ltd. · GEX · Sep 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960772
• Device Name: PHOTODERM PL.
• Applicant: Esc Medical Systems , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PhotoDerm® PL is a system intended for the treatment of benign pigmented lesions and tattoos.

Device Story

PhotoDerm® PL is an electro-optic medical device for non-invasive photothermal treatment of benign pigmented lesions and tattoos. Device delivers light energy to target tissues; principle of operation involves photothermal effect to induce lesion clearance. Used in clinical settings by trained medical professionals. Output consists of controlled light pulses; healthcare providers use device to achieve lesion removal or reduction. Benefits include effective treatment of pigmented lesions and tattoos while minimizing adverse effects in surrounding tissues.

Clinical Evidence

Multi-center clinical study conducted on benign pigmented lesions. Evaluated clearance rates and occurrence of adverse effects. Results compared to published data for predicate devices. Study concludes PhotoDerm® PL is as safe and effective as predicate devices. Theoretical study also performed to model temperature distribution in target tissues.

Technological Characteristics

Electro-optic medical device. Conforms to IEC 601.1-1 (General Requirements for Safety) and 21 CFR 1040.1 (FDA laser performance standard, where applicable). System specifications designed to be within the range of predicate laser and IR coagulation devices.

Indications for Use

Indicated for patients requiring treatment of benign pigmented lesions and tattoos.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Candela PLDL-1
• Laserscope 532nm KTP
• Redfield IR Coagulator

Submission Summary (Full Text)

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SEP 11 1996
K 96 0772

# 1. 510(K) SUMMARY- SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's name: ESC Medical Systems, Ltd

Submitter's address: Matam- Science and Industry Park
Haifa, 31905
Israel

Telephone: [phone]

Fax: [phone]

Name of device: PhotoDerm® PL

Predicate devices: Candela PLDL-1
Laserscope 532nm KTP
Redfield IR Coagulator

Description of device: PhotoDerm® PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.

## Summary:

Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the PhotoDerm® PL can be based.

It is our understanding that there are presently no FDA regulations describing the form and content of such Summaries. With this in mind, ESC Medical Systems has tried to anticipate what information may be of particular interest to the agency regarding safety and effectiveness of the PhotoDerm® PL.

## Intended use:

The PhotoDerm® PL is a system intended for the treatment of benign pigmented lesions and tattoos. The Candela PLDL-1, Laserscope 532 KTP, and the Redfield IR Coagulator have been classified as Class II devices and were reviewed by the General and Plastic Surgery Devices Panel. ESC Medical Systems claims that the PhotoDerm® PL is substantially equivalent to these devices.

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Comparing technical characteristics:

Both a technical comparison and clinical trials were performed by ESC Medical Systems to establish this equivalence:

ESC has performed a detailed comparison of the technical specifications of these predicate devices and the PhotoDerm® PL. The results have documented that the system specifications of the PhotoDerm® PL are well within the range of the technical specifications of the predicate devices.

A theoretical study was conducted to establish the temperature distribution resulting from a treatment of pigmented lesions and tattoos by the PhotoDerm® PL. The temperatures reached by a wide range of lesions, typical to benign pigmented lesions exposed to the light energy of the PhotoDerm® PL, was evaluated. It is the view of ESC Medical Systems that this analysis demonstrates that the PhotoDerm® PL is an effective treatment modality of benign pigmented lesions and tattoos, and is safe in minimizing the adverse effects in the surrounding tissues.

Performance:

In addition, ESC Medical Systems has also conducted a multi-center clinical study in which benign pigmented lesions were treated by the PhotoDerm® PL. This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the PhotoDerm® PL were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices. It is ESC’s opinion that this comparison demonstrates that the PhotoDerm® PL is as safe and as effective as predicate devices in the treatment of benign pigmented lesions.

No performance standards applicable to the PhotoDerm® PL have been adopted under Section 514 of the Act. However,

1. PhotoDerm® PL is an electro medical device and conforms with the voluntary international standard IEC601.1-1, Medical Electrical Equipment, Part 1: General Requirements for Safety.
2. Although PhotoDerm® PL is not a laser device, substantial equivalence for laser devices is being claimed. As such ESC has made efforts to comply, where applicable, with 21 CFR 1040.1 FDA laser performance standard.

In summary we believe that the analysis, the clinical data and the standards which the PhotoDerm® PL meets make it substantially equivalent to predicate devices.