Manufacturer
Focus Medical, LLCNaturaLase CO2 Laser System
Country / Region:United States (US)Submission type:Abbreviated
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K152529
- Device name
- NaturaLase CO2 Laser System
- Company
- Focus Medical, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-09-03
- Decision date
- 2016-02-04
- Submission type
- Abbreviated
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
NaturaLase CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.
Intended Use
NaturaLase CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.
Device Description
The NaturaLase CO2 Laser System includes a CO2 laser tube, power supply, closed loop cooling system, user interface control, an articulated arm, a scanning hand piece, and a traditional hand piece. The system emits a maximum power of 30 Watt at 10.6 µm. The laser energy is delivered through an articulated arm and with a scanner, distributing the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue, with the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.
Summary parsed at:2026-06-01 06:05:07 UTC
