Fiber Laser Treatment Systems (HS-232,HS-233)

The Fiber Laser Treatment Systems (HS-232 desktop and HS-233 mobile models) are Erbium (1550nm) and Thulium (1927nm) fiber lasers for dermatological procedures. The 1550nm wavelength is used for fractional skin resurfacing and soft tissue coagulation, while the 1927nm wavelength is used for soft tissue coagulation only. The system includes a mainframe with touch-screen controls, power supply, cooling system, fiber handpiece, and footswitch activation.

Both 1550nm and 1927nm lasers operate independently with selectable output sources. The 1550nm laser specifications (frequency, energy, pulse width) are similar to predicates and meet the same safety/EMC/performance standards. The 1927nm laser has a 15W output power (higher than predicate but within acceptable range) and lower minimum pulse energy that does not create new safety concerns. Both use identical handpiece tips to the predicate device K221770. The aiming beam (650nm, <2mW) and treatment area are comparable to predicates.

IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general safety); IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility); IEC 60601-2-22:2019 (surgical/cosmetic/therapeutic/diagnostic laser equipment); IEC 60825-1:2014 (laser product safety and classification).

For the 1550nm indication, the proposed device uses identical technology, specifications, and patient-contact materials (handpiece tips) as the predicate K221770, achieving the same intended use with equivalent safety profiles. For the 1927nm indication covered by predicate K130193, although output power differs slightly (15W vs. predicate range), the minor difference does not affect safety or effectiveness. The lower minimum pulse energy does not introduce new safety issues. Identical handpiece design and comparable aiming beam/treatment area parameters across both wavelengths ensure substantial equivalence despite these minor technical variations.