Public web sample
Three records and one narrow price observation for a physician buyer's research file.
Last updated: 2026-08-20
Public web sample. This edition was not sent by email. No delivery history is implied. Facts were checked against linked records through 2026-08-20.
Fast scan
Verified regulatory record
The FDA recall record identifies 26 U.S. units and ClearLink Controller software version 3.17.
Company-reported information
InMode reported $95.589 million in second-quarter 2026 GAAP revenue and a 13 percent GAAP operating margin.
Verified regulatory record
The FDA supporting-document list includes Viality under submission BK261326 with a May 13, 2026 decision date.
Dated market observation
One Texas DOTmed listing asks $27,999 for a seller-described 2022 unit with face and body attachments.
Source records
Safety record
Verified regulatory record
The FDA classifies the Photera 600 action as a Class II recall. Daavlin began the action on March 5, 2026. The FDA posted the record on July 15 and updated the page on August 17. The record was open and classified when checked on August 20.
The record lists 26 units in U.S. nationwide distribution and identifies the affected serial numbers. It directs users to check for ClearLink Controller software version 3.17. The manufacturer reason says calibrated output was calculated with an incorrect UV sensor gain. The FDA lists software design change as the determined cause, which can change before the recall is terminated.
The action asks affected users to contact Daavlin Technical Services. Daavlin states that it will place an affected device into Fixed Calibration Mode until ClearLink Controller software version 3.18 can be installed. The notice also calls for a response form and distribution of the notice to device users or a receiving facility.
A Photera owner or buyer should put four records in the equipment file: the serial-number match, the installed controller version, proof of the interim or final correction, and the service record. A used-unit inspection should also cover lamp hours, calibration records, software eligibility, and the warranty position after transfer.
The FDA record defines the recall scope and requested action. It does not establish an injury rate, predict an outcome for a patient, or compare Photera with another phototherapy system.
Source: FDA recall Z-2743-2026
Record updated August 17, 2026; accessed August 20, 2026
Manufacturer update
Company-reported information
InMode's August 5 release reports second-quarter 2026 GAAP revenue of $95.589 million, compared with $95.602 million for the second quarter of 2025. Consumables and service revenue was $22.3 million, up 13 percent from the prior-year quarter.
The release reports a 75 percent GAAP gross margin, compared with 80 percent a year earlier. GAAP operating margin was 13 percent, compared with 24 percent. Cash, cash equivalents, marketable securities, and short-term deposits totaled $501.1 million at June 30, 2026.
Management's full-year revenue outlook in the release was $365 million to $375 million. The company attributed margin changes to cost of goods sold, product mix, a North American sales-team restructuring, sales and marketing investment, and professional-services costs. The outlook and management explanations are company statements.
A quarterly result cannot answer whether a local service team will support a specific platform. It can sharpen the contract questions. Ask who services the unit in the buyer's territory, which escalation contacts are named, what response time is written into the agreement, which handpieces and software are included, and what support survives a resale.
Company results do not establish parts availability, training quality, service response, clinical performance, or counterparty strength for a specific device, distributor, or territory. Forward-looking estimates can change.
Source: InMode second-quarter 2026 company release
Released August 5, 2026; accessed August 20, 2026
FDA watch
Verified regulatory record
The FDA's 2026 cleared-submissions list includes BK261326 for Tiger Aesthetics Medical, LLC. The listed device is the Viality Lipoaspirate Wash System for Aesthetic Body Contouring, model Viality-1400. The decision date is May 13, 2026.
The list says it contains cleared 510(k) submissions with supporting documents and reflects information as of the clearance date. It also warns that later applicant or application status changes are not added to that list.
A buyer should read the supporting documents for intended use, components, contraindications, predicate, processing steps, and operating requirements. The purchase file should separate device cost, disposables, staff time, training, service, and any connected equipment. The phrase aesthetic body contouring does not make this workflow interchangeable with noninvasive energy-based systems.
A clearance record does not establish superiority, comparative clinical performance, financial return, procedure demand, or fit for a practice. The list entry alone is too narrow for a purchase comparison.
Source: FDA 2026 cleared submissions with supporting documents
Decision date May 13, 2026; accessed August 20, 2026
Price and ownership signal
Dated market observation
DOTmed listing 4706842 shows a $27,999 USD asking price for one seller-described 2022 InMode Morpheus8 RF Pro in Texas. The seller describes the condition as used and excellent, lists Morpheus8 Face and Body attachments, and states a 30-day warranty. The listing date shown on August 20 was August 7, 2026.
Configuration: Seller-described 2022 Morpheus8 RF Pro with Face and Body attachments.
One ask can set a document request, not a market range. Before comparing the number with another unit, verify the exact platform and serial number, attachment identifiers and condition, service history, software and consumable eligibility, ownership title, transfer fees, shipping, training, and the written warranty provider.
Device Pulse did not inspect the unit, contact the seller, confirm the serial number, validate the attachments, or observe a sale. The listing says items are sold as-is with no return or refund unless stated otherwise. Asking prices are not completed transactions.
Source: DOTmed listing 4706842
Listing dated August 7, 2026; accessed August 20, 2026
Open research
Check the FDA record for termination, a changed cause, or revised corrective-action instructions before citing it again.
Open the recordRead the complete supporting file before making a workflow or ownership comparison.
Open the recordCollect a dated set of comparable listings or completed transactions before publishing a range or median.
Open the recordBuyer move of the week
For any used unit, ask the manufacturer and seller to state in writing whether the serial number can receive software updates, parts, service, training, and consumables after transfer. Record who provides each warranty and what happens if the device fails inspection before acceptance.
A low asking price can leave the buyer with a platform that cannot be serviced or transferred on the expected terms. The contract needs the serial number, included attachments, inspection window, rejection right, shipping responsibility, and refund path.
Research shortcut
The printable checklist keeps regulatory scope, service, software, training, consumables, transfer rules, and downside assumptions in one file.
Open the buyer kitSend this page to the person who reviews clinical evidence, the person who owns the capital budget, and the person who will manage service calls. Keep the direct source links with the interpretation. A forwarded summary without the identifier, date, configuration, or limitation loses the part that makes it useful.
If a colleague owns an affected unit or has an active quote, ask them to open the live record. FDA recall status and manufacturer instructions can change after an archive date. A company release can be replaced by a later filing. A marketplace listing can change or disappear without proving that a unit sold.
Use the public archive for prior issues, the Buyer’s Guide for device research, the research methodology for evidence rules, and the visible correction section when a material record changes. Signup is optional. This sample was not sent by email.
No. It is a public web sample rebuilt locally for the Phase 1 format review. No subscriber list was contacted.
No. The FDA record identifies specific serial numbers and ClearLink Controller software version 3.17. Check the live record and manufacturer instructions for a unit.
No. Company results can prompt contract and service questions, but they do not establish support quality for a product or territory.
No. It is one seller-controlled asking price for one listed unit. No completed sale was observed.
No. Clearance addresses a regulatory pathway and stated use. Comparative results, ownership cost, and practice fit require other evidence.
A material correction should state the date, changed text, reason, and source on the web issue. Later issues should link back when an open item changes.
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