XTRAC Excimer Laser
Medical device recall Z-1455-2017. Published in FDA’s Enforcement Report on Apr 5, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 5, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- US - 1000 , Foreign - 612 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
US - 1000 , Foreign - 612, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SN 80007 80009 80010 80011 80018 80019 80020 80025 80031 80037 80038 80042 80043 80047 80061 80069 80073 80074 80077 80084 80092 80094 80097 80099 80102 80104 80113 80115 80116 80119 80121 80122 80124 80125 80128 80131 80134 80150 80151…
Every code shown here, 1,995 characters
SN 80007 80009 80010 80011 80018 80019 80020 80025 80031 80037 80038 80042 80043 80047 80061 80069 80073 80074 80077 80084 80092 80094 80097 80099 80102 80104 80113 80115 80116 80119 80121 80122 80124 80125 80128 80131 80134 80150 80151 80156 80158 80160 80161 80164 80168 80169 80174 80176 80177 80183 80186 80187 80193 80195 80199 80203 80208 80219 80221 80224 80225 80232 80238 80248 80249 80256 80257 80258 80259 80261 80278 80280 80293 80294 80298 80304 80310 80312 80314 80315 80317 80326 80327 80334 80336 80339 80348 80351 80352 80355 80358 80359 80360 80366 80369 80370 80372 80378 80379 80381 80386 80388 80391 80394 80397 80398 80402 80414 80417 80420 80426 80427 80430 80434 80435 80437 80440 80451 80452 80456 80462 80463 80466 80472 80477 80479 80480 80486 80493 80496 80497 80498 80499 80501 80503 80504 80507 80512 80513 80525 80529 80530 80534 80545 80561 80563 80564 80570 80572 80575 80582 80583 80586 80587 80595 80602 80607 80608 80609 80620 80626 80630 80631 80634 80637 80638 80646 80653 80656 80663 80664 80671 80672 80674 80686 80690 80696 80701 80706 80712 80713 80714 80717 80722 80726 80729 80735 80737 80739 80740 80743 80746 80748 80765 80766 80773 80777 80779 80781 80785 80793 80800 80807 80814 80815 80830 80839 80840 80847 80855 80863 80873 80955 80956 80958 80961 80962 80963 80964 80965 80968 80972 80973 14001 14003 14007 14008 14009 14016 14018 14019 14022 14024 14026 14029 14030 14037 14040 14043 14044 14046 14047 14050 14051 14053 14054 14055 14059 14060 14064 14065 14067 14068 14071 14072 14073 14074 14077 14078 14081 14083 14084 14085 14089 14092 14095 14105 14107 14110 14111 14112 14113 14114 14115 14116 14117 14121 14122 14123 14125 14129 14137 14138 14139 14140 14143 14144 14145 14148 14149 14150 14153 14154 14155 14158 14159 14160 14162 14163 14164 14165 14166 14167 14168 14169 14170 14171 14172 14173 14174 14175 14176 14177 14178 14179 14181 14182 14183 14184 14185 14186 14187 14189 14190 14191 14192 14193 14194 14195 14196 14197 14199…
FDA’s list runs to 6,002 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
USA (nationwide) Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 23, 2017.
- FDA classified it on Mar 27, 2017.
- FDA’s Enforcement Report published it on Apr 5, 2017.
- FDA terminated it on Jun 5, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Strata Skin Sciences, Inc., of Carlsbad, CA.
- Who began it, in FDA’s words: FDA Mandated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,002 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.