Zap Lasers, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Zap Lasers, LLC makes
Zap Lasers, LLC manufactures surgical diode laser systems and handheld microlasers for medical procedures. The SOFTLASE G2-SURGICAL DIODE LASER SYSTEM is designed for precision tissue ablation, while the SOFTLASE PRO, ORTHOLASE, and HYGIENELASE models serve specific clinical applications in dermatology, orthopedics, and infection control. The STYLA MICROLASER and STYLAORTHO are compact devices for targeted laser treatments in surgical and orthopedic settings.
These devices are classified as Class II under FDA regulations and are recorded in the 510(k) premarket notification database. The company is based in the United States.
Catalogue
Softlase - Surgical Diode Laser System Ref K003440
510(k) 510(k)Softlase G2-Surgical Diode Laser System Ref K021227
510(k) 510(k)Softlase Pro, Ortholase And Hygienelase Ref K091796
510(k) 510(k)Styla Microlaser And Stylaortho Ref K081214
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Zap Lasers, LLC, initiated on 2008-08-08. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 8 Aug 2008 Z-0587-2010 Unclassified (pre-2012) Terminated The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.
Frequently asked questions
How many devices does Zap Lasers, LLC have in the registry?
The registry currently lists 4 devices for Zap Lasers, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zap Lasers, LLC's devices?
Among its 4 most recently registered devices, Zap Lasers, LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do Zap Lasers, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Zap Lasers, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Zap Lasers, LLC?
FDA recall records list 1 recall initiated by Zap Lasers, LLC, the most recent initiated on 2008-08-08. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Zap Lasers, LLC in the registry?
The most recently registered devices listed for Zap Lasers, LLC include SOFTLASE - SURGICAL DIODE LASER SYSTEM, SOFTLASE G2-SURGICAL DIODE LASER SYSTEM, SOFTLASE PRO, ORTHOLASE AND HYGIENELASE and STYLA MICROLASER AND STYLAORTHO.