SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL

K962109 · Classy Lady by Mehl of Puerto Rico, Inc. · GEX · Mar 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K962109
• Device Name: SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL
• Applicant: Classy Lady by Mehl of Puerto Rico, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.

Device Story

Laser instrument for hair removal; utilizes selective photothermolysis principle; operates via ruby laser source; delivers energy to skin for depilation; used in dermatology practice by physicians; eliminates need for carbon-based lotions or pretreatment waxing; output affects hair density reduction; clinical benefit includes effective hair removal without scarring or purpuric reactions.

Clinical Evidence

Three clinical studies conducted. One study reported 38.4% of sites receiving single treatment achieved 100% reduction in hair density after average of 72 days. No safety issues identified; no scarring or purpuric reactions observed. Transient hyper- and hypopigmentation noted, resolving within months.

Technological Characteristics

Ruby laser source; operates via selective photothermolysis; Class II device (21 CFR 878.4810); Product Code 79GEX.

Indications for Use

Indicated for the removal of unwanted body and facial hair in patients seeking dermatological depilation.

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

• Spectrum Model RD-1200 (K910422)
• ThermoLase LT-100 Q-Switched Nd:YAG laser (K950019)

Submission Summary (Full Text)

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K96 2109
MAR 13 1997
CLASSIFIED AlphaMakHac
4020 Newberry Road
Suite 400
Gainesville, Florida 32607
Phone [phone] FAX [phone]

# 510(k) SUMMARY

## MEHL QD RUBY LASER
## SYSTEM FOR HAIR REMOVAL

The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair. Reviewed by the General and Plastic Surgery Device Classification Panel, medical lasers are assigned the Product Code 79GEX and are regulated under 21 CFR 878.4810 as Class II (Performance Standards) devices.

From an operational standpoint the Mehl QD Ruby Laser is substantially equivalent to any number of laser devices, including the Spectrum Model RD-1200 (K910422), used in Dermatology practice. They produce the same wavelength, deliver the same energies to the skin, and are constructed of similar components.

With respect to its patented procedure for removing hair, the Mehl QD Ruby Laser is substantially equivalent to the ThermoLase LT-100 Q-Switched Nd:YAG laser (K950019) in that,

1. Both types of lasers are widely used for dermatological applications;
2. Each is based upon the same technological characteristics;
3. Both employ the same principle of selective photothermolysis for depilitation, although the Mehl laser achieves the same or better effect without the use of the carbon-based lotion and pretreatment waxing required by the ThermoLase system;
4. The ability of the ruby laser to remove hair was measured in three clinical studies. In one of these studies, 38.4% of the sites receiving only one treatment showed a 100% reduction in hair density after an average of 72 days.

In all three studies, no safety issues were identified. No scarring or purpuric reactions were observed, though skin discoloration (hyper- and hypopigmentation) was noted, but was seen to resolve within a few months.

Thomas Blake, R.Ph.
REGULATORY STRATEGIST
5/29/96 Date

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