Robert,
I have not found any information on SoftLight 2.0. A significant change from the
present hardware or lotion could require filing of a new FDA 510(K), as would
any change in the claimed efficacy.
In the Q3 10Q, filed 28 July, TLZ claims to have seen promising results in the
laboratory, which if confirmed, would lead to introduction early in Q4. That would
leave only two months for the confirming tests and a new FDA clearance.
Since FDA clearance itself takes about 3 months (rarely less, often longer), it
appears that TLZ does not intend to seek a new 510(k) clearance for SoftLight
2.0. Therefore, I doubt that the change in process and claimable efficacy is
significant.
As for Laser Industries' EpiTouch, it is a ruby laser, combining both Q-switched
and long-pulse mode in one unit; the former for tatoos and pigmented lesions;
the latter for hair removal. In long pulse mode, its fluence ranges between 25
and 40 J/cm^2, with a pulse-width of 1.2 ms (according to the Canadian
distributor, Surgimedic). Palomar's Epilaser operates between 10 and 75
J/cm^2, with a 3 ms pulse width. I doubt there will be any material difference in
their effectiveness. Neither can claim permanent or long-term results.
The 510(k), K962446, was cleared on 7 Mar 97. The summary can be downloaded from:
fda.gov
Regarding clinical trials, it says, "Clinical data on 31 patients with a 3 month
follow-up period was presented in order to demonstrate the safety and efficacy
of the device."
As expected, based on the limited size and duration of the trial, only temporary
hair removal can be claimed, for up to three months.
The predicate devices to which Laser Industries claimed substantial
equivalence were the Thermolase LT-100 (aka SoftLight), Spectrum Epilaser,
and the American Hair Removal System (AHRS). I find the latter a
fascinating choice, as I will explain.
The AHRS is an electronic tweezer device that received FDA clearance in 1990
(K892514), and can claim permanent hair removal. This claim is controversial,
because it was based on a self-test for electrologists issued by an electrology
professional organization, requiring clearance of at least 40 percent of hairs by
9 weeks post-treatment.
I believe that FDA made an error in accepting this as a protocol to determine
the permanence of new processes, because it is too short a period of time, and
a very minimal standard. My electrologist says it is not even a sufficient self-test
for her profession, setting far too low a standard. Various electrified tweezers
have been marketed for hair removal for 20 years, yet I have seen no credible
evidence that any of them are better than ordinary tweezers.
That Laser Industries claimed substantial equivalence to the AHRS device
leeds me to speculate that they may have been trying obtain a label for
permamance, since it is quite possible that a laser could clear 40 percent of hair
for 9 weeks. I believe the FDA no longer accepts this 9 week test as a valid
protocol for new devices (this does not affect AHRS), so Laser Industries could
not have succeeded with such a strategy.
I remain unconvinced of the worth of laser hair removal to consumers.
Treatments cost 10 to 20 times that of waxing, but do not provide a
commensurate improvement in duration of hair removal. That is a recipe for
failure, as TLZ demonstrated thus far.
Ted Molczan |
