FDA 510(k) clearance: Lasers and flash lamps

FDA 510(k) clearances: Lasers and flash lamps

Beginning in 1976, the US Food and Drug Administration (FDA) began requiring new medical devices to demonstrate they were substantially equivalent to a product marketed before 1976. FDA classifies lasers and flash lamps as follows:

  • Device Classification Name: Laser instrument, surgical, powered
  • Regulation Number: 878.4810
  • Product Code: GEX

Product Code GEX

Lasers and flashlamps cleared for hair removal by FDA since 1976:

Device Company Date cleared 510(k)
SoftLight Thermolase 04/03/95 K950019
Epilaser Palomar/Spectrum 03/05/97 K963947
Chromos 694 Mehl/Biophile 03/13/97 K962109
EpiTouch ESC/Sharplan 03/07/97 K962446
LaseAway Polytec/Lambda 06/24/97 K971193
EpiLight ESC/Sharplan 07/07/97 K963249
PhotoGenica LPIR Cynosure 08/08/97 K971737
Chromos 694 (rev) Mehl/Biophile 08/01/97 K971814
Sharplan ruby ESC/Sharplan 08/27/97 K972099
cool tip Cynosure 08/27/97 K972002
Starlight diode Coherent Star 12/03/97 K973324
5000 alex ESC/Sharplan 12/04/97 K973354
Medlite Continuum 12/23/97 K973719
cool tip Candela 02/10/98 K974381
Epilaser (rev) Palomar 03/10/98 K980160
PhotoDerm HR ESC/Sharplan 05/20/98 K974536
MLT r694 UK Medical Laser Technologies 04/03/98 K980187
LightSheer lp ruby Palomar 05/04/98 K980420
Mehl (scanner) Mehl/Biophile 06/29/98 K980753
GentleLASE (rev) Candela 07/13/98 K981351
Epilaser (perm reduct) Palomar 07/21/98 K980517
LaseAway Alex Silver Creek Surgical 12/16/98 K982316
(cool tip) Laserscope 12/18/98 K984110
GentleLASE (cool tip) Candela 02/04/99 K984601
LightSheer ruby (perm reduct) Palomar 03/04/99 K982980
MedLite yag (no prep) Continuum 2/10/99 K983054
LightSheer Diode (perm reduct) Coherent Star 04/08/99 K982940
RubyStar Aesclepion 07/12/99 K991285
ThermaLight 2000 Jennifer Maxx[1] 09/10/99 K992630
Apex 800 IRIDEX 12/09/99 K992298
Softlight (w handpiece) Thermolase 12/23/99 K993209
Delight II Radiancy 12/27/99 K992482
M2 alex Cynosure 01/18/00 K994427
PhotoDerm/EpiLight (perm reduct) ESC/Sharplan 01/27/00 K991935
EpiLight/MultiLight all skin ESC/Sharplan 02/24/00 K994014
EpiStar Nidek 02/27/00 K990119
CoolGlide Altus (Apex) 03/06/00 K991798
NaturaLase Focus Medical[2] 04/24/00 K992597
SLP diode Palomar 05/18/00 K994225
GentleLASE (perm reduct) Candela 05/26/00 K994260
MeDioStar H Aesclepion 06/01/00 K994116
Apogee (perm reduct) Cynosure 06/29/00 K992757
Athos Cosmos 08/31/00 K001704

[1] The ThermaLight device by Jennifer Maxx is cleared as equivalent to the D’Plume Photoepilator by Carol Block.

[2] The NaturaLase device was cleared under the device name LT-100 by manufacturer LORAD. This company no longer makes the LT-100.

Source: Releasable 510(k) Database (type in GEX under Product Code to list all laser and accessory clearances)