FDA.reportPublic FDA data

LAMBDA SPA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076897293008697515LAMBDA SPA1N2026-01-01via dell impresa 1 Brendola Vicenza IT 36040

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1027511341936058K102036DOCTOR SURGERY DIODE LASERS FAMILYGEX2010-09-28
1027511630721560K091562DOCTOR SMILE A-810 AND B-980 LASERSGEX2009-09-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX22010-09-28

GUDID#

Doctor Diode Laser - Doctor Diode Laser Family including Doctor Smile Wiser (LA3D0001.3) is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures.

LAMBDA SPA

2016-12-01

Doctor Smile - Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics.The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items:08056093610062 – B-980 Laser08056093611090 - protective glasses 08056093611120 and/or 08056093611137 handpieces 08056093611083 and/or 08056093611052 and/or 08056093611069 and/or 08056093611076 fibers

LAMBDA SPA

2016-12-15

Doctor Diode Laser - Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items:– 08056093610024 Wiser Laser- 08056093611090 or 08056093611106 protective glasses - 08056093611120 and/or 08056093611137 handpieces - 08056093611113 and/or 08056093611007 and/or 08056093611045 and/or 08056093611038 and/or 08056093611014 and/or 08056093611021 tips

LAMBDA SPA

2016-12-01

Doctor Smile - Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oralsoft tissues, Laser soft tissue curettage, whitening.The laser kit includes a wireless foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items:08056093610116 - Doctor smile wiser 2 08056093611106 and 08056093611090 - protective glasses 08056093611007 - Wiser tip endodontics08056093611014 - Wiser tip periodontics08056093611021 - Wiser tip surgery08056093611038 - Wiser tip implant

LAMBDA SPA

2018-01-30

Doctor Smile - Doctor Smile A-810 laser is a standard diode medical laser with 810 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oralsoft tissues, Laser soft tissue curettage, whitening.The laser kit includes a foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items:08056093610055 - A-810 Laser08056093611106 - protective glasses 08056093611120 and/or 08056093611137 handpieces 08056093611083 and/or 08056093611052 and/or 08056093611069 and/or 08056093611076 fibers

LAMBDA SPA

2016-12-15