FOTONA SKINLIGHT LASER SYSTEM

K962902 · Medical Laser Solutions · GEX · Jan 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K962902
• Device Name: FOTONA SKINLIGHT LASER SYSTEM
• Applicant: Medical Laser Solutions
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The laser is intended to be used for cutting, vaporizing, and coagulating soft tissue.

Device Story

Fotona Skinlight is an Er:YAG laser system (2.94 µm wavelength) used for soft tissue surgery. System components include high-voltage power supply, water-to-air cooling, Er:YAG laser rod, articulated arm delivery system, focusing handpiece, and microprocessor controller. Device operates in non-contact mode; flashlamp-pumped crystal generates up to 1.0 Joule pulses at 300 µs pulsewidth and 15 Hz frequency. Red diode aiming beam assists targeting. Physician selects parameters via microprocessor controller. Laser energy ablates/coagulates tissue via selective photothermolysis. Used in clinical settings for surgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and comparison to predicate device.

Technological Characteristics

Flashlamp-pumped Er:YAG laser; 2.94 µm wavelength; 1.0 Joule max pulse energy; 300 µs pulsewidth; 15 Hz max frequency. Articulated arm delivery system with focusing handpiece. Microprocessor-based controller for parameter selection. Internal water-to-air cooling system. Non-contact operation.

Indications for Use

Indicated for cutting, vaporizing, and coagulating soft tissue.

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

• Schwartz Electro-Optics (SEO) TriLase 2940 (K953585)

Reference Devices

• Anderson, RR 'Selective Photothermolysis: precise microsurgery by selective absorption of pulsed radiation', Science 220
• Drnovsek, B 'Clinical Applications of the Skinlight Er:YAG laser', Dermatology and Aesthetic Surgery, vol 1.2
• Walsh, AJ, and Cummings, C, 'Dynamic Heating of water exposed to erbium laser pulses', 1994, Las.Surg.Med., 15(3)
• Kaufman, R., Hartmann, A, Hibst, R. 'Cutting and Skin-Ablative properties of pulsed mid-infrared laser surgery', 1994, J.Dermat.Surg.Oncol. 20
• Kaufman, R., Hibst, R. 'Pulsed 2.94 um Er:YAG laser skin ablation-experimental results and first clinical application', 1990, Clin.Exp.Derm., 15
• Hibst, R., Kaufman, R. 'Effects of laser parameters on pulsed Er:YAG laser skin ablation', 1990, Las.Med.Sc., 6

Submission Summary (Full Text)

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Premarket notification : Fotona Skinlight Laser
JAN 10 1997

# Appendix F : Summary of Safety and Effectiveness Data

## General Information and Description

1942902

The Fotona Skinlight system is based on Er:YAG laser technology. Within the system, an optical cavity contains the Er:YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode.

The System is capable of emitting up to 1.0 Joule of pulsed light at $2.94\ \mu\mathrm{m}$, with a (nominal) pulsewidth of $300\ \mu\mathrm{s}$. The laser is intended to be used for cutting, vaporizing, and coagulating soft tissue.

The Skinlight system is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.

c) An Er:YAG laser rod, capable of generating 1.0 Joule optical pulses at a frequency up to $15\ \mathrm{Hz}$.

d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

## Summary of Substantial Equivalence

Fotona believes that its Skinlight system is substantially equivalent to the Schwartz Electro-Optics (SEO) TriLase 2940 (K 953585).

The TriLase 2940 is cleared for the cutting, vaporization, and coagulation of soft tissue. It therefore has the same Intended Use as the Fotona Skinlight.

Fotona Skinlight 510(k) submission, crb510k2.doc

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Premarket notification : Fotona Skinlight Laser

Technologically, the predicate has identical characteristics to Skinlight, both comprising a flashlamp pumped Er:YAG laser rod generating light at a wavelength of 2.94 µm, which is subsequently delivered to the patient via an articulated delivery arm and focusing handpiece.

Both devices have identical energy delivery capabilities and similar repetition rates.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

## Appendix G : Reference Literature

1. Anderson, RR "Selective Photothermolysis: precise microsurgery by selective absorption of pulsed radiation", Science 220, p 524-527.

2. Drnovsek, B "Clinical Applications of the Skinlight Er:YAG laser", Dermatology and Aesthetic Surgery, vol 1.2.

3. Walsh, AJ, and Cummings, C, 'Dynamic Heating of water exposed to erbium laser pulses', 1994, Las.Surg.Med., 15(3), pp.295-305.

4. Kaufman, R., Hartmann, A, Hibst, R. 'Cutting and Skin-Ablative properties of pulsed mid-infrared laser surgery', 1994, J.Dermat.Surg.Oncol. 20, 112-118.

5. Kaufman, R., Hibst, R. 'Pulsed 2.94 um Er:YAG laser skin ablation-experimental results and first clinical application', 1990, Clin.Exp.Derm., 15, 389-393.

6. Hibst, R., Kaufman, R. 'Effects of laser parameters on pulsed Er:YAG laser skin ablation', 1990, Las.Med.Sc., 6, 391-7.

Fotona Skinlight 510(k) submission, erb510k2.doc