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)