FDA.reportPublic FDA data

Dermatological frequency-doubled solid-state laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.
GUDID devices
168
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850069558130Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-BS-A2026-03-02
00850069558147Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-BS-B2026-03-02
00850069558154Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCLB272BH-BS-C2026-03-10
00850069558161Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-AG-A2026-03-02
00850069558178Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-AG-B2026-03-02
00850069558185Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-AG-C2026-03-02
00850069558192Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-REG-A2026-03-02
00850069558208Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-REG-B2026-03-02
00850069558215Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-REG-C2026-03-02
00850069558222Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-BS-A2026-03-02
00850069558239Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-BS-B2026-03-02
00850069558246Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-BS-C2026-03-02
00850069558253Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-AG-A2026-03-02
00850069558260Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-AG-B2026-03-02
00850069558277Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-AG-C2026-03-02
00850069558284Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-REG-A2026-03-02
00850069558291Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-REG-B2026-03-02
00850069558307Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-REG-C2026-03-02
00850069558314Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-BS-A2026-03-02
00850069558321Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-BS-B2026-03-02
00850069558338Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-BS-C2026-03-02
00850069558345Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-AG-A2026-03-02
00850069558352Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-AG-B2026-03-02
00850069558369Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-AG-C2026-03-02
00850069558376Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-REG-A2026-03-02
00850069558383Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-REG-B2026-03-02
00850069558390Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-REG-C2026-03-02
00850069558406Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-AG-A2026-03-02
00850069558413Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-AG-B2026-03-02
00850069558420Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-AG-C2026-03-02
03830054237742StarWalkerFOTONA d.o.o.M031-3A/2 PICO Pro2025-10-20
08059173393060Suprema VT+QUANTA SYSTEM SPAPCMS005032023-02-13
08059173393077Suprema 4VQUANTA SYSTEM SPAPCMS005042023-02-13
08800035501174PicoLO BodyLaseroptek Co.,LtdPicoLO Body2021-04-23
08800035501303PicoLO Premium BodyLaseroptek Co.,LtdPicoLO Premium Body2022-01-06
08800035501310PicoLO Premium ArmLaseroptek Co.,LtdPicoLO Premium Arm2022-01-06
08800035501327PicoLO Premium Zoom HandpieceLaseroptek Co.,LtdPicoLO Premium Zoom Handpiece2022-01-06
08800035501334PicoLO Premium DIA FX 1064 HandpieceLaseroptek Co.,LtdPicoLO Premium DIA FX 1064 Handpiece2022-01-06
08800035501341PicoLO Premium DIA FX 1064 S HandpieceLaseroptek Co.,LtdPicoLO Premium DIA FX 1064 S Handpiece2022-01-06
08800035501358PicoLO Premium DIA FX 532 HandpieceLaseroptek Co.,LtdPicoLO Premium DIA FX 532 Handpiece2022-01-06
08800035501365PicoLO Premium S20 HandpieceLaseroptek Co.,LtdPicoLO Premium S20 Handpiece2022-01-06
08800035501372PicoLO Premium Collimator HandpieceLaseroptek Co.,LtdPicoLO Premium Collimator Handpiece2022-01-06
08800035501389PicoLO Premium User ManualLaseroptek Co.,LtdPicoLO Premium User Manual2022-01-06
08800035501396PicoLO Premium Foot SwitchLaseroptek Co.,LtdPicoLO Premium Foot Switch2022-01-06
08800088300007BRIGHTONELTRA GLOBAL Co., Ltd.BRIGHTONE2026-05-07
08800088300014MIINLTRA GLOBAL Co., Ltd.MIIN2026-05-07
16973511890006SANOBeijing Sano Lasers S&T Development Co., Ltd.SHE-LSP101-12025-07-04
06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.10642026-03-23
00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCLB272BH-BS-C2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-REG-A2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-REG-B2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-REG-C2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-BS-A2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-BS-B2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-AG-A2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-AG-B2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB272BH-AG-C2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-REG-A2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-REG-B2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-REG-C2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-BS-A2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-BS-B2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-BS-C2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-AG-A2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-AG-B2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB365BH-AG-C2026-03-02
00850069558703Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-REG-A2026-03-02
00850069558710Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-REG-B2026-03-02
00850069558727Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-REG-C2026-03-02
00850069558734Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-BS-A2026-03-02
00850069558741Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-BS-B2026-03-02
00850069558758Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-BS-C2026-03-02
00850069558765Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-AG-A2026-03-02
00850069558772Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-AG-B2026-03-02
00850069558789Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB550BH-AG-C2026-03-02
00850069558796Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-REG-A2026-03-02
00850069558802Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-REG-B2026-03-02
00850069558819Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-REG-C2026-03-02
00850069558826Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-AG-A2026-03-02
00850069558833Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCLB940BH-AG-B2026-03-02