Biolase.
Irvine dental-laser company whose 2016 filing traces the firm to Marseille in 1984 and manufacturing of Waterlase systems in California.
- Dental Manufacturer
- USA
- Operatory Equipment
About Biolase
BIOLASE's Form 10-K for the year ended 31 December 2016 says the company was formed as Societe Endo Technic, SA, in 1984 in Marseille, France, merged in 1987 into Pamplona Capital Corp., a Delaware holding company, changed its name to BIOLASE Technology, Inc. in 1994, and changed it to BIOLASE, Inc. in 2012. The filing says all laser systems were manufactured, assembled, and tested at the Irvine, California, headquarters, in a 57,000-square-foot facility with about 20,000 square feet for manufacturing and warehousing, ISO 13485 certified and FDA-registered.
The same filing says Waterlase uses a patented combination of water and laser energy for soft and hard tissue, and that diode systems cover soft tissue, pain therapy, and cosmetic procedures including whitening. It says the company had about 230 issued and 85 pending US and international patents, mostly related to Waterlase, and that from 1998 through 31 December 2016 it sold about 33,600 laser systems in more than 90 countries, including over 11,800 Waterlase systems. Those counts are as of that 10-K, not a current census.
An encyclopedia history of the predecessor says Waterlase, first called Millennium, was designed in 1995 and 1996 as an Er:YSGG laser and received FDA hard-tissue clearance in October 1998. Dentistry Today's manufacturer note says Waterlase technology was introduced in 1996 and uses YSGG energy with water, and that headquarters and manufacturing are in Irvine. Dates of first sale and first clearance should stay attached to those sources. A diode and a Waterlase are not the same device.
This profile uses the 2016 filing for the plant and the corporate origin because that is a primary company document. Later ownership, address, and model names can change. Ask the seller for the current IFU and the current service depot before you buy a handpiece or a tip on the strength of the 10-K alone. The filing says the strategy was to manufacture in-house when that was efficient, and that the Irvine site handled design through servicing under the ISO 13485 system. A tip that is out of stock is not a reason to substitute another laser company's tip. The encyclopedia account also describes earlier Nd:YAG systems, Laser-35 and Nylad, that preceded Waterlase and were not the hydrokinetic product. If a used laser is offered under an old model name, match it to the clearance for that model rather than to the Waterlase indication.
Key Offerings
Product and equipment lines dentists commonly associate with Biolase.
Waterlase
The 2016 10-K calls Waterlase the all-tissue system that combines water and laser energy for procedures otherwise done with drills or scalpels. The encyclopedia account dates FDA hard-tissue clearance to October 1998. Tip and power settings are model-specific.
Diode lasers
The 10-K lists diode systems for soft tissue, pain therapy, and cosmetic uses including whitening. A diode is not a Waterlase. Do not use Waterlase settings on a diode.
Tips and accessories
Laser systems need the tips cleared with that model. The 10-K describes in-house assembly in Irvine as of 2016. Confirm whether a replacement tip is still supplied from that facility.
Training
A laser purchase is not complete without the user's training and the state rules for laser use. The 10-K does not substitute for a credential.
Who BIOLASE suits
BIOLASE suits a practice comparing an all-tissue Waterlase with a diode for soft tissue. Lasers are compared on the dental laser guide.
Hard-tissue clearance and soft-tissue clearance are different. Read the indication for the serial number, not the brand slogan.
Water and wavelength
Waterlase, as the 10-K describes it, is water plus laser energy. A diode in the same catalog does not use that hydrokinetic claim. Keep the manuals apart.
The 33,600-system figure ends at 31 December 2016. It is not a current installed-base number.
Irvine manufacturing, as filed
The 2016 10-K says systems were built at the Irvine headquarters under ISO 13485. Ask whether that is still the manufacturing site for the model on your quote.
Patents cited in the filing protect technology. They do not list a price or a clinical success rate.
Questions buyers ask
Where did BIOLASE start?
The 2016 10-K says the company began as Societe Endo Technic in Marseille in 1984, merged into a Delaware company in 1987, took the BIOLASE Technology name in 1994, and became BIOLASE, Inc. in 2012.
What is Waterlase?
The 10-K describes Waterlase as the all-tissue laser that combines water and laser energy. An encyclopedia account of the company dates FDA hard-tissue approval to October 1998. Diode lasers in the same filing are a separate soft-tissue line.
Where were the lasers built?
As of the 2016 10-K, BIOLASE manufactured, assembled, and tested laser systems at its Irvine, California, headquarters in an ISO 13485, FDA-registered facility. Confirm the current site before you rely on that sentence for a new order.
Which guide matches this purchase?
Use the dental laser guide. Wavelength and indications still come from the device clearance and the IFU.